MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.2MMX30MM RNGLC+ ACET DRL BIT; INSTRUMENT, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2023

Event Type  malfunction  

Event Description

It was reported drill bits were bending and breaking while attempting to drill.There was no consequences or impact to the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00229 and 0001825034-2023-00230.The 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

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: g3; h2; h3; h6.Mechanical (g04) ¿ drill.Two (2) 3.2mmx30mm rnglc+ acet drl bit, part # 31-323230 from lot 65783001, were returned and evaluated against the complaint.Visual inspection found 1 drill bit to be bent.The other bit has a fractured tip.Nicks and light scratching are present on the shafts.Sem2302-005: ductile overload dimples were found throughout the fracture surface.A possible bending hinge was also identified.The fracture artifacts suggest a possible bending overload failure mode.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined, however sem analysis suggest bending overload as the failure mode.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: 3.2MMX30MM RNGLC+ ACET DRL BIT
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16372860
• MDR Text Key: 309514181
• Report Number: 0001825034-2023-00228
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00887868478703
• UDI-Public: (01)00887868478703(17)321205(10)65783001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• 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: 31-323230
• Device Lot Number: 65783001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Female