MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-03-21 for 2.5 MM MALE HEX DRIVER N/A 42509902500 manufactured by Zimmer Biomet, Inc..
[103038611]
(b)(4). Complaint sample was evaluated and the reported event was confirmed. Visual examination of the returned parts determined that they had scratches suggesting repeated use. Sem micrographs and eds elemental analysis of the debris on the femoral provisionals was conducted and it was found that rust like indication on the laser etched areas which showed high concentration of (o- oxygen, mn-manganese and cl-chlorine) and the debris indication areas were mechanically smeared and were filled with debris which predominantly showed oxides and some areas showed chlorine- cl, carbon-c, silicon- si, calcium-ca and aluminum-al. Dhr was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required. Investigation results concluded that the reported event was due to maintenance issue as some of the chemical elements do not come from the instruments, but could come from hard water. The black residue is spread on each and all the instruments, which is only possible through contact with air and water. The recommended cleaning steps were not followed based on the provided information. 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 will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[103038612]
It was reported that during the initial operating room (o. R. ) setup the nurse was handling the persona femoral provisionals and noticed black residue on her gloves. On the inside of the femoral provisionals black debris was noticed in all left and right femoral provisionals. All 5 sets were examined and all had the same black debris.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-01685 |
| MDR Report Key | 7356897 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-03-21 |
| Date of Report | 2018-04-11 |
| Date of Event | 2017-05-08 |
| Date Mfgr Received | 2018-03-21 |
| Device Manufacturer Date | 2015-05-22 |
| Date Added to Maude | 2018-03-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2.5 MM MALE HEX DRIVER |
| Generic Name | KNEE INSRUMENT |
| Product Code | GFC |
| Date Received | 2018-03-21 |
| Returned To Mfg | 2017-06-09 |
| Model Number | N/A |
| Catalog Number | 42509902500 |
| Lot Number | 56578138 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-21 |