UNKNOWN DRILL
Report
- Report Number
- 0009613350-2025-00404
- Event Type
- Injury
- Date Received
- June 9, 2025
- Date of Event
- August 19, 2024
- Report Date
- March 11, 2026
- Manufacturer
- ZIMMER GMBH
- Product Code
- HAW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10. PROXIMAL HUMERUS, LEFT, LONG, ÿ 7X260MM ITEM# 47249626107, LOT# 3181184. CORTICAL BONE SCREW, ÿ 4X36MM ITEM# 47248613640, LOT# 3024634. CORTICAL BONE SCREW, ÿ 4X28MM ITEM# 47248612840, LOT# 3132468. CORTICAL BONE SCREW, ÿ 4X24MM ITEM# 47248612440, LOT# 3200532. PROXIMAL HUMERUS NAIL CAP, ÿ 10.5X7.5MM ITEM# 47248801007, LOT# 3136299. G2. REPORT SOURCE: SPAIN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H11. THE REPORTED EVENT WAS CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. MEDICAL RECORDS & RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED THAT DURING THE PROCEDURE THE DRILL BROKE WITHOUT THE ABILITY TO REMOVE IT FROM THE BONE ON (B)(6) 2024. THE PIECE OF FRACTURED DRILL BIT WAS SUBSEQUENTLY REMOVED DURING IMPLANT REMOVAL ON (B)(6) 2025. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1, A2, B4, B5, B7, E1, G3, G6, H2, H6, H11. E1. THERE WAS A SECONDARY SURGEON REPORTED. NAME: DR. (B)(6).
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B1, B2, B4, B5, G3, G6, H2, H6, H11.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED DUE TO MISSING REFERENCE AND LOT NUMBERS. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED. CORRESPONDENCE REPORTS THAT THE CAUSE OF THE REPORTED EVENT MIGHT BE INCORRECT SURGICAL TECHNIQUE; HOWEVER, DUE TO THE LACK OF INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE WITH AFFIXUS HUMERAL NAIL, THE DRILL BROKE. THE SUBJECT WAS REPORTED AS IMPROVED/RECUPERATED THE DAY AFTER THE SURGERY. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO ADDITIONAL EVENT INFORMATION.
IT WAS REPORTED THAT A PATIENT HAD AN INITIAL INTRAMEDULLARY NAILING OF THE LEFT PROXIMAL HUMERUS. DURING THE PROCEDURE, A DRILL BIT BROKE AND WAS RETAINED IN THE BONE. THE FRAGMENT WAS REMOVED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE WITH AFFIXUS HUMERAL NAIL, THE DRILL BROKE. AN INTRAOPERATIVELY INFECTION WAS CONFIRMED BY SUBSEQUENT POSITIVE CULTURES INCLUDING SONIFICATION SAMPLES FROM THE IMPLANT. REVISION SURGERY WAS PERFORMED APPROXIMATELY ONE YEAR AND 1 MONTH POST IMPLANTATION, BROKEN DRILL PART WAS REMOVED, THE PATIENT ALSO HAS DEBRIDEMENT AND INTRAVENOUS ANTIBIOTIC TREATMENT. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1632162 | UNKNOWN DRILL | INSTRUMENT, HIP | HAW | ZIMMER GMBH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Female | Hospitalization| R | SEE H11 NARRATIVE. |