4.3MM CROWE POINT TWIST DRILL
Report
- Report Number
- 0001825034-2021-01970
- Event Type
- Malfunction
- Date Received
- July 7, 2021
- Date of Event
- June 9, 2021
- Report Date
- November 22, 2021
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- HTW
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- 003
Narratives
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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G7, H1, H2, H4, H10 THIS LOT WAS ISSUED TO 7 FINAL LOT NUMBERS. PLEASE SEE THE BELOW MANUFACTURING INFORMATION: LOT 522560; MANF DATE: JUL 10, 2012; EXPIRY DATE: JUN 30, 2022 LOT 522570; MANF DATE: JUL 11, 2012; EXPIRY DATE: JUN 30, 2022 LOT 522580; MANF DATE: JUL 12, 2012; EXPIRY DATE: JUN 30, 2022 LOT 540590; MANF DATE: JUL 14, 2012; EXPIRY DATE: JUNE 30, 2022 LOT 821610; MANF DATE: FEB 21, 2013; EXPIRY DATE: FEB 28, 2023 LOT 613870; MANF DATE: SEP 29, 2011; EXPIRY DATE: AUG 31, 2021 LOT 705180; MANF DATE: NOV 02, 2011; EXPIRY DATE: SEP 30, 2021 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. \VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE TIP IS FRACTURED. THE PRODUCT SHOWS SIGNS OF REPEATED USE; NICKS, SCRATCHES, AND WEAR MARKS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS EVENT IS BEING FURTHER INVESTIGATED IN IE-20007. AFTER RECEIPT, THE VISUAL REVIEW IDENTIFIED SEVERAL MARKINGS ON THE DEVICE THAT SUGGESTS THE DEVICE TO BE USED MULTIPLE TIMES. THE DEVICE LABELING INDICATED THE DEVICE TO BE SINGLE-USE. AFTER DISCUSSION WITH THE SPAIN LOANER, IT WAS DETERMINED THAT THE TEAM DOES NOT HAVE A WAY TO DETERMINE, OUTSIDE OF PHYSICAL MARKINGS, WHICH ITEMS IN A KIT ARE SINGLE-USE AND IF THE SINGLE-USE DEVICES WERE USED IN SURGERY. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
T WAS REPORTED THAT THE INSTRUMENT WAS FOUND TO BE FRACTURED DURING AN INSPECTION AT THE WAREHOUSE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1029131 | 4.3MM CROWE POINT TWIST DRILL | TRAUMA, INSTRUMENT | HTW | ZIMMER BIOMET, INC. | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose |