LACTOSORB SYSTEM 14 MM RAPID FLAP
Report
- Report Number
- 0001032347-2018-00857
- Event Type
- Injury
- Date Received
- December 12, 2018
- Date of Event
- April 8, 2018
- Report Date
- July 10, 2019
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- JEY
- PMA / PMN Number
- K003281
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00858-1.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE TWO (2) LACTO 14MM RAPIDFLAP CLAMP (PART# 915-0020, LOT# 810100, 930760) WERE NOT RETURNED FOR INVESTIGATION AND NO PHOTOS WERE PROVIDED. FOR THESE REASONS, THE CLAMPS CANNOT BE VISUALLY EVALUATED OR FUNCTIONALLY TESTED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE TWO CLAMPS WERE RETURNED WITHOUT ORIGINAL PACKAGING IN BIOHAZARDOUS BAGS. THE CLAMPS WERE VIEWED THROUGH THE BAGS AND WERE NOTED TO HAVE DARK RED RESIDUE, RESEMBLING BLOOD AND INDICATING A USE ATTEMPT. THE POST WAS ALSO CLEARLY FRACTURED, THE COMPLAINT IS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE POST EXPERIENCING FORCE IN EXCESS OF WHAT IT WAS DESIGNED TO ENCOUNTER DURING THE ATTEMPTED USE. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00858-3.
ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED WHEN THE SURGEON WAS FIXING THE CLAMPS, THE SUPPORT BAR BROKE. IT WAS CONFIRMED NO BROKEN PARTS WERE LEFT IN THE PATIENT. IN REGARDS TO THE INDICATION THE SURGICAL TECHNIQUE WAS NOT FOLLOWED, THE DISTRIBUTOR STATED THIS WAS AN ERROR WHEN COMPLETING THE COMPLAINT FORM.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
ZIMMER BIOMET COMPLAINT (B)(4), FOREIGN COUNTRY: (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 MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00858.
IT WAS REPORTED THE CLAMPS BROKE DURING SURGERY. IT IS UNKNOWN IF THIS RESULTED IN A FOREIGN BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER CLAMP OF THE SAME SIZE. IT IS STATED THE SURGICAL TECHNIQUE WAS NOT FOLLOWED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 994557 | LACTOSORB SYSTEM 14 MM RAPID FLAP | PLATE, BONE | JEY | BIOMET MICROFIXATION | N/A | 810100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |