MAUDE Adverse Event Report: BIOMET ORTHOPEDICS STRAIGHT MAGNUM INSERTER 1/4-28 THREADED ROD KIT; HIP INSTRUMENT

Model Number N/A

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

It was reported that during a procedure, upon impaction of the femoral head, the tip of the inserter was damaged.Another inserter was available to complete the procedure without patient injury or significant delay.

Manufacturer Narrative

Report source: (b)(6).Complaint sample was evaluated and the reported event was confirmed.The device exhibits minor damage on the threads, specifically nicks in several locations.Regardless of the damage to the threads, the thread gage could be successfully threaded onto the rod and fully seated.The inserter exhibits signs of repeated use over a potential field service lifetime of approximately 4 years.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined however; possible cause of the failure may be due to improper handling.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: STRAIGHT MAGNUM INSERTER 1/4-28 THREADED ROD KIT
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6210258
• MDR Text Key: 63713909
• Report Number: 0001825034-2016-05354
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

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: S313142
• Device Lot Number: ZB130502
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 03/06/2018
• Supplement Dates FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2013
• 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