MAUDE Adverse Event Report: ZIMMER SPINE FINAL SCREWDRIVER SHAFT II

Catalog Number	046W1AN00641
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that the tip of a java instinct screwdriver shaft fractured during surgery.All parts were retrieved by the surgeon and there was no reported patient harm or injury.
Additional Manufacturer Narrative
Corrected information in d4: udi number, d10, h3, and h5.Additional information in h6: method, results, and conclusions.This follow-up report is being submitted to relay additional information and initially corrected information.The complaint is non-verifiable for one (1) out of one (1) instinct java final driver (part number "046w1an00641") for the reported failure of tip fracture.Visual inspection confirmed the fracture.Medical records were not provided for review.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any product holds initiated prior to the notification date.Device usey this device is used for treatment.Corrective/preventive action no corrective or preventive actions are recommended at this time.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported that the tip of a java instinct screwdriver shaft fractured during surgery.All parts were retrieved by the surgeon and there was no reported patient harm or injury.

• Brand Name: FINAL SCREWDRIVER SHAFT II
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• MDR Report Key: 10817249
• Report Number: 3003853072-2020-00112
• Device Sequence Number: 1114657
• Product Code: NKB
• UDI-Device Identifier: 00889024342194
• UDI-Public: (01)00889024342194(10)A270190
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 046W1AN00641
• Device Lot Number: A2701901A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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
• Patient Age: 65 YR
• Patient Weight: 70