MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. STANDARD CANNULATED DRIVER; SCREWDRIVER

Catalog Number	730M0060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: visual inspection revealed the tip is twisted/deformed and fractured.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 part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.
Event or Problem Description
It was reported the tips of two cannulated drivers broke while implanting screws in the pelvis.The tips were retrieved.There was no reported patient harm.This is report two of two for this event.

• Brand Name: STANDARD CANNULATED DRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 12677740
• Report Number: 3012447612-2021-00407
• Device Sequence Number: 11836828
• Product Code: HXX
• UDI-Device Identifier: 00887868273681
• UDI-Public: (01)00887868273681(10)AC69
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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 Catalogue Number: 730M0060
• Device Lot Number: AC69
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1