MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 POSITIONING GUIDE ROD; INSTRUMENT, HIP

Model Number N/A

Device Problem Device Damaged by Another Device (2915)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the positioning guide rod was damaged during shell implantation.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed that the guide was fractured.The tip of the rod was bent in the direction of the overload.Minor surface damage was observed indicating the guide has been used multiple times.Fracture analysis of the rod identified fracture features consistent with failure due to torsional overload.Review of the device history records for part # 110018822 with lot zb150801 identified no deviations or anomalies that may have caused or contributed to the reported event.Review of the supplier device history record for part # 110018822 with lot zb150801 identified deviation(s) within the production run.Surface discoloration, and had been accepted after rework with polish; burrs at the first teeth of thread, and had been accepted after rework with polish; "rework was performed and accepted, therefore, it is not expected that this would affect the reported event.2 pieces scrap".Because these pieces were scrapped, it is not expected that this would affect the reported event.The root cause of the reported event was determined to be torsional overload.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: G7 POSITIONING GUIDE ROD
• Type of Device: INSTRUMENT, 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: 7040869
• MDR Text Key: 93073594
• Report Number: 0001825034-2017-09905
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 110018822
• Device Lot Number: ZB150801
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 10/30/2018
• Supplement Dates FDA Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• 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