MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DEPTH GAUGE; HIP INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by the zimmer biomet and the investigation is in process.Once the investigation is completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a hip procedure, the physician was attempting to bend the g7 depth gage to fit the augment better and it snapped in half.There was no reported harm or injury to 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.Complaint sample was returned and evaluated against the reported event.Visual inspection identified the tip of the device had fractured.Sem analysis of the g7 depth gage sample showed that it fractured due to bending overlaod.Eds semi-quantitative elemental analysis of the fracture showed that it was consistent with 410 stainless steel.Dhr was reviewed and no discrepancies were found.The root cause of the reported event is attributed to off-label use of the device which is confirmed by sem analysis of the bending overload.Additionally, the rep stated the surgeon was trying to bend the device.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: G7 DEPTH GAUGE
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10711116
• MDR Text Key: 213915890
• Report Number: 0001825034-2020-03838
• 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
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

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: 110010717
• Device Lot Number: 493623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1