MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 1.3 MM SQUARE SCREWDRIVER

Model Number	2312-18-012
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: 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 mdr will be submitted.
Event or Problem Description
It was reported that the screwdriver broke during the surgery, with the broken piece not able to be removed from the screw head.The broken piece is retained in the patient body.There was a surgical delay of 10 minutes.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified the tip to be rounded.The overall length was measured and found to be short confirming the tip was fractured off and not returned.There are discoloration spots throughout the part.Light nicks and scratches were also found on the part.Hardness found to be conforming.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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.
Event or Problem Description
No additional event information is available at the time of this report.

• Brand Name: 1.3 MM SQUARE SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10307345
• Report Number: 0001825034-2020-02832
• Device Sequence Number: 10963639
• Product Code: HXX
• UDI-Device Identifier: 00887868026324
• UDI-Public: (01)00887868026324
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2312-18-012
• Device Catalogue Number: 231218012
• Device Lot Number: 178565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FP16 PEG FULL THREAD 2.5X16MM UNKNOWN; FP16 PEG FULL THREAD 2.5X16MM UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention