MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 STR INSRTR THREADED SHAFT; INSTRUMENT, HIPS

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: foreign: country: japan.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 during an initial hip arthroscopy, the inserter tip cracked during use.Some of the debris were found, but not the smaller pieces.The surgeon commented that the pieces could have been aspirated by suction.Surgical technique was used.There was no adverse patient impact and no medical interventions.There was also no surgical delay.No additional information available.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The product was returned and evaluated.Medical records were not provided.A visual examination of the returned product identified that the device was fractured at the threaded tip location.There was scuffing and indentations to the hex feature of the device.The fracture surface features appear to be related to a bending overload of the threaded tip.A review of the device history records identified no deviations or anomalies during manufacturing.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The reported issue was confirmed based on the evaluation of the returned product; however, a definitive root cause cannot be determined.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 STR INSRTR THREADED SHAFT
• Type of Device: INSTRUMENT, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18897139
• MDR Text Key: 337586832
• Report Number: 0001825034-2024-00706
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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: 110003452
• Device Lot Number: 355235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2014
• 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