MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE UNKNOWN TOGGLELOC; FASTENER, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patient mentioned in the journal article.Initial reporter - the article was written by james r.A.Smith and rouin amirfeyz.Product location unknown.

Event Description

Information was received based on review of a journal article titled ¿does immediate elbow mobilization after distal biceps tendon repair carry the risk of wound breakdown, failure of repair, or patient dissatisfaction?¿ which aimed to assess whether two week immobilization after distal bicep repair is a necessary part of rehabilitation.The study followed 20 patients (22 bicep tendon repairs) performed between september 2012 and october 2014.Fourteen patients were identified in the article that underwent distal bicep tendon repairs and subsequently experienced transient nerve paresthesia, which all resolved by the eight week follow up.

• Brand Name: UNKNOWN TOGGLELOC
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 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: 5886992
• MDR Text Key: 52490722
• Report Number: 0001825034-2016-03148
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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