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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
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 reports 3003853072-2021-00118 through 3003853072-2021-00120.
Event or Problem Description
It was reported the tips of two final screwdriver shafts broke intra-operatively while final tightening the blockers.The fragments were recovered and the procedure was completed using another final driver shaft without patient impacts.This is report three of three for this event.
Event or Problem Description
It was reported the tips of two final screwdriver shafts broke intra-operatively while final tightening the blockers.The fragments were recovered and the procedure was completed using another final driver shaft without patient impacts.This is report three of three for this event.
Additional Manufacturer Narrative
Device evaluation: visual inspection revealed fractured tips on 3 instinct java final screwdriver shafts.Potential cause: root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.It could also be attributed to off-axis forces applied during use.Dhr review: per dhr review, the parts were likely conforming when they left zimmer biomet control.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.

• 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
• Manufacturer (Section G): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 12761629
• Report Number: 3003853072-2021-00120
• Device Sequence Number: 3144864
• Product Code: NKB
• UDI-Device Identifier: 00889024342194
• UDI-Public: (01)00889024342194(10)A2701901A(11)180612
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 55 KG