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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 01/07/2021

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 the screw depth gage was found in fractured at the sterilization department within the hospital.There was no patient involvement.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.Root cause was unable to be determined.A g7 depth gauge, part # 110010717 from lot 438360, was returned and evaluated against the complaint.Visual inspection confirmed the tip to be fractured at the distal most notch.The shaft of the gage is dinged.Scratching was observed on the handle.The etching has become faded.Sem analysis of the g7 depth gage sample showed that it fractured due to bending overload.Suspected crack initiation areas identified near the gage surface.Quasi-cleavage mode of overload fracture near the crack initiation area exhibiting ductile dimples on brittle cleavage planes.Ductile overload sheared dimples identified near the opposite edge of the gage fracture, indicating crack exit area.Eds semi-quantitative elemental analysis of the fracture showed that it was consistent with 410 stainless steel.Device has a potential field age of approximately 5 years.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: G7 DEPTH GAUGE
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11272315
• MDR Text Key: 230050108
• Report Number: 0001825034-2021-00298
• Device Sequence Number: 1
• Product Code: LXH
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• 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: 438360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1