MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.5 MM HEX CANNULATED SCREWDRIVER STANDARD QUICK-CONNECT; INSTRUMENT, TRAUMA

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Udi : (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 while inserting the screw, the tip of the screwdriver broke.The tip of the screwdriver remains in the head of the screw and the screw is in the plate.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A screw driver was returned for evaluation.Visual examination of the returned product identified tip of the product has fractured and not all the pieces were returned.The device has nicks and gouges indicating use of the device.The device has approximately 2 years of field age and it is unknown how many times the device was used.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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 further event information available at the time of this report.

• Brand Name: 2.5 MM HEX CANNULATED SCREWDRIVER STANDARD QUICK-CONNECT
• Common Device Name: INSTRUMENT, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10071066
• Report Number: 0001822565-2020-01710
• Device Sequence Number: 19757014
• Product Code: HXX
• UDI-Device Identifier: 00889024061064
• UDI-Public: (01)00889024061064
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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: N/A
• Device Catalogue Number: 00236016625
• Device Lot Number: 64124080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other