MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE SILICONE DRILL DRIVER; INSTRUMENT, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an initial procedure, the surgeon was drilling into the acetabulum to place screws into the cup and the head of the flexible drill shaft broke off.There was no harm to the patient, and another drill bit was used to finish the case with no delay.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: g3; h2; h3; h4; h6.One flexible silicone drill driver item# 110010733, lot# 154264, was returned and evaluated.Upon visual inspection the device had fractured at the head location exposing the inner spring.There are visible bumps on the black sheath.Fracture surface analysis performed by sem on the flexible silicone drill driver sample showed that the wires were suspected to have fractured due to overload.Wire fractures on the flexible silicone drill driver sample showed severe smearing which obscured the evidence of crack initiation area.The wire fractures showed ductile overload dimples in the non-smeared areas, indicating a possible ductile overload tensile mode of fracture.Eds semi-quantitative elemental analysis of the wire on the flexible silicone drill driver showed that it was consistent with 304 stainless steel.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot 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.

• Brand Name: FLEXIBLE SILICONE DRILL DRIVER
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10976694
• MDR Text Key: 220463911
• Report Number: 0001825034-2020-04300
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110010733
• Device Lot Number: 154264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1