MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CALIBRATED FLEXIBLE DEPTH GAGE E; INSTRUMENT, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2020

Event Type  malfunction  

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.

Event Description

It was reported that depth gauges broke during an initial tha.Physician bent depth gauges and broke them.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the fractured depth gage is that the doctor tried to straighten the depth gauge and it snapped.Per ifu, under care and handling section 1.Surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, and rough or improper handling.One calibrated flexible depth gage e item# 424492 lot# 675360 was returned and evaluated.Upon visual inspection the depth gage had fractured at the measuring tip.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

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

• Brand Name: CALIBRATED FLEXIBLE DEPTH GAGE E
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10757856
• MDR Text Key: 213863095
• Report Number: 0001825034-2020-03939
• Device Sequence Number: 1
• Product Code: HTJ
• 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: 04/06/2021

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
• Device Catalogue Number: 424492
• Device Lot Number: 675360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 04/05/2021
• Supplement Dates FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1