MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN DEPTH GAGE; INSTRUMENTATION, HIP

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00-6250-065-30 j6854352 bone screw 6.5x30 selftap; 00-6250-065-25 j6829076 bone screw 6.5x25 selftap; 31-323240 457210 3.2mmx40mm rnglc+ acet drl bit; 110010273 6937512 g7 osseoti multihole 70mm i; 110031017 64844474 vivacit-e dm bearing 28x54mm; 00-6250-065-60 63469615 bone screw 6.5x60 selftap; 00-6250-065-30 j6849822 bone screw 6.5x30 selftap; 00-6250-065-50 j6910092 bone screw 6.5x50 selftap; 110024467 457020 g7 dual mobility liner 54mm i; 31-323230 534180 3.2mmx30mm rnglc+ acet drl bit.Reported event was confirmed by review of photographs received.Visual inspection of provided picture identified the gauge had fractured.Device history record (dhr) 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the depth gauge fractured during surgery.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN DEPTH GAGE
• Type of Device: INSTRUMENTATION, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12703549
• MDR Text Key: 282392422
• Report Number: 0001825034-2021-02972
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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
• Report Date: 10/26/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Male