MAUDE Adverse Event Report: BIOMET TRAUMA ADD 5MM IMPING 1ST; ROD, FIXATION

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

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

Event Date 11/25/2016

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 the endcap couldn't be inserted into the nail.The surgeon used and finished the surgery with an alternative one with no patient injury reported.

Manufacturer Narrative

This report is being submitted to reflect additional information not available at the time of the initial submission.Current information remains insufficient to determine the cause of the event.(b)(4).

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.The end cap was received for evaluation.It was found that there is sufficient damage to the leading thread which likely was the cause of the device not being able to be inserted into the nail, thus the complaint is confirmed.The dimensions of the threads was not conducted as there was damage to the threads.The device history records were reviewed and no deviations or anomalies were identified.A definitive root cause of the reported issue cannot be determined with the information provided.

• Brand Name: ADD 5MM IMPING 1ST
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 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: 6247637
• MDR Text Key: 64723059
• Report Number: 0001825034-2017-00047
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK033878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• 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: 181701051
• Device Lot Number: M06957 F
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1