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

Model Number N/A

Device Problems Degraded (1153); Fracture (1260); Device Damaged by Another Device (2915)

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

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.There are warnings in the package insert that this type of event may occur.Under precaution it states, "instrument that have experience use of excessive force are susceptible to fracture'.

Event Description

It was reported that the inserter was damaged upon impaction.A second inserter was used to complete the procedure.

Manufacturer Narrative

This follow-up report is being filed to report additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

The complaint sample was evaluated and reported event was confirmed.Visual inspection of the returned sample shows minimal damage to the threads.Threads were found to conform to specifications.Device history record was reviewed and no deviations or anomalies were found that would lead to the reported event.A root cause cannot be identified with the information provided.A summary of the investigation has been sent to the complainant.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: ORTHOPEDIC MANUAL SURGICAL 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: 6211011
• MDR Text Key: 63472984
• Report Number: 0001825034-2016-05421
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2018

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: ZB120701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided; 04/26/2018
• Supplement Dates FDA Received: 01/23/2017; 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2012
• 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