MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.2MMX20MM RNGLC+ ACET DRL BIT; INSTRUMENT, HIPS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).The device will not be returned for analysis, as it has been discarded by the hospital; however, an investigation of the reported event is in progress.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: 0001825034-2020-04372.

Event Description

It was reported that during surgery, while drilling holes to put screws, the surgeon split the bits of both instruments inside the same loaner kit.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.D11: catalog#: 31-323240 3.2mmx40mm rnglc+ acet drl bit lot#: ni.Catalog#: 31-323260 3.2mmx60mm rnglc+ acet drl bit lot#: 886570.Catalog#: 31-323240 3.2mmx40mm rnglc+ acet drl bit lot#: 798350.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to 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.

Event Description

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

• Brand Name: 3.2MMX20MM RNGLC+ ACET DRL BIT
• Type of Device: INSTRUMENT, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11029554
• MDR Text Key: 222283643
• Report Number: 0001825034-2020-04371
• 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,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• 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: 31-323220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CAT#: 31-323240 DRILL BIT LOT#: NI; SEE H10 NARRATIVE