MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL PIN AND SCREW INSERTER; EXTRACTOR

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will be returned to zimmer biomet for investigation.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 the surgery the distal end of the pin driver fractured into two pieces.All pieces were found.No piece fell into the patient body.There were no consequences on the patient¿s health or life.There are no contributing events.There is no additional information available at this time.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, d4, d10, g4, g7, h1, h2, h3, h6, and h10.Visual examination of the returned product found signs of repeated use (surface scratches) and the tip has fractured.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Device was submitted for further analysis.Analysis determined the device fractured due to bending overload.Eds semi-quantitative elemental analysis of the item showed that it was consistent with 455 stainless steel.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.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: DRILL PIN AND SCREW INSERTER
• Type of Device: EXTRACTOR
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10148484
• MDR Text Key: 195094599
• Report Number: 0001822565-2020-02072
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00590102100
• Device Lot Number: 64051676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1