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

Catalog Number 31-323230

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/27/2020

Event Type  Injury  

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.Udi: (b)(4).Concomitant medical products: item # 31-323230/3.2 mm x30 mm rnglc+ acet drl bit/ lot # 676610.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -02395.

Event Description

It was reported that during a hip surgery the first drill bit bent during use and the second drill bit fractured in the patient¿s acetabulum.A third was used to complete the surgery.The surgeon ended up leaving a piece of the second drill bit in the patient.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: b4; b5; g4; g7; h1; h2; h3; h6.A 3.2mmx30mm rnglc+ acet drl bit, part # 31-323230 from lot 798260, was returned and evaluated against the complaint.Visual inspection confirmed that the drill bit is fractured.The shaft exhibits wear rings around the non-fluted portion of the bit.The fracture occurred at the same location on the bit as the bend of lot 676610.The fractured tip was not returned as it was retained by the patient.Sem analysis of the drill bit sample showed that it suspected to have fractured to due to reverse bending overload.Eds semi-quantitative elemental analysis of the drill bit fracture surface showed that it was consistent with 455 stainless steel.The dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found 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: 3.2MMX30MM RNGLC+ ACET DRL BIT
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10179067
• MDR Text Key: 195939297
• Report Number: 0001825034-2020-02397
• 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: 09/01/2020

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 Catalogue Number: 31-323230
• Device Lot Number: 798260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 09/01/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other