MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CLASSIC SCREWDRIVER; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a screwdriver can no longer retain its screw.This was discovered during routine inspection.
Additional Manufacturer Narrative
Inspection: the returned devices match the information in the complaint file and were examined.Visual inspection revealed that the driver has a fractured tip.Dhr review: the dhr was reviewed.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.Potential root cause: a definitive root cause cannot be determined with the information provided.An off-axis force applied during surgery or wear and tear from multiple uses and sterilization cycles may have contributed to this event.Device usage: this device is used for treatment.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 screwdriver was found to have fractured off during a routing inspection.There was not a patient present at the time of discovery.

• Brand Name: CLASSIC SCREWDRIVER
• Common Device Name: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11842498
• Report Number: 3012447612-2021-00183
• Device Sequence Number: 4662322
• Product Code: NKB
• UDI-Device Identifier: 00889024336377
• UDI-Public: (01)00889024336377(10)62ZD
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K132884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 3558-1
• Device Lot Number: 62ZD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/17/2021
• 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