MAUDE Adverse Event Report: BIOMET ORTHOPEDICS STRAIGHT INSERTER 1/4-28 THREAD KIT; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Damaged by Another Device (2915)

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

Event Date 10/23/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

It was reported that upon impaction, the tip of the inserter was damaged.Another inserter was used to complete the procedure.No additional information provided.

Manufacturer Narrative

This follow-up report is being filed to report a correction.

Manufacturer Narrative

This follow-up report is being filed to report a correction.

Manufacturer Narrative

Complaint is confirmed with the visual inspection.Dimensional measurement of the shank diameter found no deviation from the print specification.The device shows repeated use.Surgical notes were not provided.Threads of the device likely damaged during the cup impaction.Device history record was reviewed and it shows that the product was incorrectly heat treated and this possibly contributed to the failure of the device.However with the information provided, 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.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed repeated use and visible damage.Device history record (dhr) was reviewed and no discrepancies were found relevant to the reported event.Root cause of the event could not 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: STRAIGHT INSERTER 1/4-28 THREAD KIT
• Type of Device: PROSTHESIS, HIP
• 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: 6180441
• MDR Text Key: 62539471
• Report Number: 0001825034-2016-05236
• 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: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/03/2017

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: ZB130302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/12/2017; 10/16/2017
• Supplement Dates FDA Received: 01/20/2017; 02/20/2017; 09/13/2017; 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1