MAUDE Adverse Event Report: BIOMET TRAUMA K-WIRE STAINLESS STEEL 1.6X127MM NS; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Date 07/13/2016

Event Type  Injury  

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.The following could not be completed with the limited information provided.Device product code - ni, expiration date - ni, manufacture date ¿ ni.Product requested, not yet received.

Event Description

During a trauma procedure, the k-wire became fused with the plate and could not be moved.The plate and k-wire were removed and another plate was used to complete the procedure.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Medical product - dvr anatomic narw short left, catalog#: dvransl lot#: j3601979.Therapy date - (b)(6) 2016.The complaint devices were returned stuck together confirming the complaint.These devices were deemed to be conforming to specification as a result of manufacturing record review and dimensional analysis.The root cause could not be determined.

• Brand Name: K-WIRE STAINLESS STEEL 1.6X127MM NS
• Type of Device: PLATE, FIXATION, BONE
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5917197
• MDR Text Key: 53569200
• Report Number: 0001825034-2016-03403
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: KW062SS
• Device Lot Number: NXX360J
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention