MAUDE Adverse Event Report: BIOMET TRAUMA RETRO FEMORAL CONNECTING BOLT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.(b)(4).Review of manufacturing history found no evidence of product non-conformance and device likely left the manufacturer conforming to print.Examination of the device confirmed the reported condition, as thread damage was observed on the connecting bolt.A conclusive root cause of the event cannot be determined with the available information.There are warnings in the package insert that state that this type of event can occur: under care and handling, it states, "surgical instruments are subject to wear with normal usage.Instruments,which have experienced extensive use or excessive force, are susceptible to fracture.Surgical instruments should only be used for their intended purpose.".

Event Description

During a procedure, the connecting bolt stripped as the femoral nail was inserted.There was no patient injury or delay in the procedure.

• Brand Name: RETRO FEMORAL CONNECTING BOLT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 6031260
• MDR Text Key: 57555136
• Report Number: 0001825034-2016-04132
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2016

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: 14-442021
• Device Lot Number: 977880
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2016
• 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
• Patient Age: 27 YR