MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CALIBRATED DRILL 4.3MM SHORT; TRAUMA, INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 47249236013; greater trochanter femoral nail; lot# 63948458.Report source: (b)(6).The product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04887.Product not returned.

Event Description

It was reported that during surgery, the femoral nail was explanted immediately after the implantation as the drill interfered while drilling the descending proximal screw hole.Subsequently, the tip of the drill was fractured inside the patient.The fractured part was able to removed from the patient.The surgery was completed with an alternative nail.It was noticed after the surgery that the right nail had holes for the left.No additional information is available.

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.Visual inspection of the returned product noted holes are machined in an incorrect orientation in relation to the nail.The drill was not returned to perform additional evaluation.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.The lot number of the drill is not provided, so a dhr review could not be performed.The incorrect orientation of the holes in the nail lead to the drill bit interference with the nail and fracturing.The root cause is determined as a manufacturing deficiency.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CALIBRATED DRILL 4.3MM SHORT
• Type of Device: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9411216
• MDR Text Key: 169086525
• Report Number: 0001822565-2019-04891
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00249006443
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 43