MAUDE Adverse Event Report: BIOMET TRAUMA 3.5MM CORT SCREW STERILE 32MM; SCREW, FIXATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/15/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects it states, "loosening, bending, cracking or fracture of the orthopaedic screw, intramedullary nail, plate, and screw-plate combination or loss of fixation in bone attributable to nonunion, osteoporosis, markedly unstable comminuted fractures.".

Event Description

It was reported that patient underwent an unknown initial procedure on (b)(6) 2015.During the procedure, the screw head fractured during insertion through the humeral nail.Part of the screw was retained by the patient.No further information has been provided.

Manufacturer Narrative

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

Event Description

It was reported that patient underwent proximal humeral versa nailing system procedure on (b)(6) 2015.During the procedure, the screw head fractured during insertion through the humeral nail.Part of the screw was retained by the patient.No further information has been provided.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Evaluation of the device determined a potential root cause from over torquing during insertion of the screws.

• Brand Name: 3.5MM CORT SCREW STERILE 32MM
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5163883
• MDR Text Key: 28823249
• Report Number: 0001825034-2015-04387
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK905048
• 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: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 181835032
• Device Lot Number: DNNB59
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2012
• 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
• Patient Outcome(s): Other