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

Catalog Number	046W1AN00641
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2020
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.Reference report 3007472424-2020-00002.Not returned to manufacturer.
Event or Problem Description
It was reported that during a surgery, two final drivers' tips broke off.A third driver was used to complete the case.There was no reported impact on the patient.This is report one of two for this event.
Additional Manufacturer Narrative
(b)(4).D11 - medical product: catalog #: 046w1an00641, final scrdrv shaft rigid ij, lot # a2453206a.Reported event was confirmed from the returned devices with fractured tips.Device history record 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
It was further reported that there was a fifteen minute delay and that it is unknown if the patient retained the tips.

• 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: 10673671
• Report Number: 3007472424-2020-00001
• Device Sequence Number: 14226627
• Product Code: NKB
• UDI-Device Identifier: 00889024342194
• UDI-Public: (01)00889024342194(10)A2667309A(11)180528
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: A2667309A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 10/29/2020
• 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: SEE H10
• Patient Age: 52 YR
• Patient Weight: 60