MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 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	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
It was reported that the tip of a final driver fractured during surgery.An alternative driver was used to complete the procedure without reported patient impacts.
Event or Problem Description
It was reported that the tip of a final driver fractured during surgery.An alternative driver was used to complete the procedure without reported patient impacts.
Additional Manufacturer Narrative
The complaint is confirmed for 1 instinct java final screwdriver shaft rigid for the reported failure of the tip fracturing during an operation.Visual inspection confirmed that the tip of the driver is fractured.However, a definitive root cause for the damage was unable to be determined.Medical records were not provided for review.The dhr was reviewed.There were no nonconformances or temporary deviations associated with this failure on this lot.All characteristics inspected upon initial receipt were found conforming to specifications.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.This device is used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.If any information is received which changes the information in this report, a follow up report will be submitted.

• Brand Name: FINAL SCREWDRIVER SHAFT II
• Common Device Name: INSTINCT JAVA SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• MDR Report Key: 10714497
• Report Number: 3003853072-2020-00107
• Device Sequence Number: 17070974
• Product Code: NKB
• UDI-Device Identifier: 00889024342194
• UDI-Public: (01)00889024342194(10)A2667308AR(11)181206
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

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: A2667308AR
• 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: 09/22/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 77