MAUDE Adverse Event Report: ZIMMER SPINE FINAL SCREWDRIVER SHAFT II; INSTINCT JAVA SYSTEM

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection revealed the tip has fractured.Medical records were not provided for review.Potential cause: the cause of the damage cannot be determined at this time since there is no information available regarding how the instrument was being used or handled at the time of the damage.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report , a follow-up report will be sent.
Event or Problem Description
It was reported that a final driver was worn during surgery.However, the tip was found to have fracture off when the device was evaluated by the manufacturer.Another driver was used to complete the surgery without patient impacts.

• Brand Name: FINAL SCREWDRIVER SHAFT II
• Common Device Name: INSTINCT JAVA SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• MDR Report Key: 11574810
• Report Number: 3003853072-2021-00022
• Device Sequence Number: 17009457
• Product Code: NKB
• UDI-Device Identifier: 00889024342194
• UDI-Public: (01)00889024342194(10)A2649802A(11)180302
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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 Model Number: N/A
• Device Catalogue Number: 046W1AN00641
• Device Lot Number: A2649802A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR