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	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 mdr will be submitted.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
It was reported that while tightening the screw during the procedure, the tip of the screwdriver fractured off and was left inside the patient's body.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Corrected: d4 (lot#).Reported event was unable to be confirmed due to limited information received from the customer.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 event.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, g3, g6, h2, h6, h10.The complaint sample was returned and visual examination of the product identified light scratches and nicks on the surface and the tip had fractured off.The root cause remains unchanged at this time.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.

• 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: 11595624
• Report Number: 0001825034-2021-00950
• Device Sequence Number: 3570889
• Product Code: HXX
• UDI-Device Identifier: 00887868026324
• UDI-Public: (01)00887868026324
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2021

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: 130662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 07/14/2021; 09/08/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 07/30/2021; 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR