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 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - (b)(6).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 the pin driver fractured.There is no additional information at this time.

Event Description

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

Manufacturer Narrative

Visual examination of the returned product confirms that the screwdriver was fractured and passed the dimensional and material analysis.Device was submitted for further analysis.Analysis determined that the instrument fracture due to bending overload.The crack initiated in the inner diameter and traveled towards outer diameter.Quasi-cleavage mode of overload fracture identified throughout the fracture surface.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.However, follow up indicates that the surgeon didn't follow proper surgical technique but the information doesn't point what step was not followed or any other information, therefore, it is unknown whether pin driver fracture resulted from the surgical technique issue.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.

Manufacturer Narrative

This report is being submitted to update the complaint description, udi number, lot number, and manufacturing date.

Event Description

It was reported that the pin driver snapped during the procedure.The screw was removed with pin extractor and none of the product fell into the patient.It was further reported that the surgical technique was not followed.There is no additional information at this time.

• 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: 9380452
• MDR Text Key: 199667492
• Report Number: 0001822565-2019-05061
• 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,Followup
• Report Date: 04/09/2020

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: 63600355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 11/27/2019; 04/06/2020
• Supplement Dates FDA Received: 12/17/2019; 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1