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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Ossification (1428); Nerve Damage (1979); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification were not provided for the patients mentioned in the journal article.The following sections could not be completed with the limited information provided.Date of event - unknown.Device code - unknown.Expiration date - unknown.Date implanted - unknown.Date explanted - unknown.Initial reporter - the article was written by kodde et al in the journal of knee surgery sports traumatology arthroscopy (2015), doi: 10.1007/s00167-013-2571-3g.Pma/510(k) number.Manufacture date.(b)(4).Product location unknown.

Event Description

Information was received based on review of a journal article titled, "reconstruction of distal biceps tendon ruptures with a cortical button" which aimed to evaluate the results of a cortical button reconstruction technique in patients with a traumatic distal biceps tendon rupture, using the toggleloc, manufactured at legacy biomet.This study consisted of 22 patients with 24 traumatic distal biceps tendon ruptures underwent surgical treatment between 2007 and 2010.The median age at time of injury was 49 years and dominant arm was involved in 55% of patients.Before may 2009, the repair was done using a competitor product, and after, the repairs were performed using the toggleloc.The journal article reports the following complications: (b)(4) cases of dysfunction of the posterior interosseous nerve.(b)(4) case of symptomatic partial re-rupture of the distal biceps tendon.(b)(4) case of awareness of the cortical button, resolved by the button being removed.(b)(4) case of entrapment of the lateral antebrachial cutaneous nerve.(b)(4) case of crepitus from heterotrophic ossification.(b)(4) case of irritation from the fixation sutures of an allograft.(b)(4) case of an elongated biceps tendon which required a reconstruction.(b)(4) cases with radiographic signs of heterotrophic ossification around the insertion area after average 2 years.In conclusion, the distal biceps tendon reconstructions with a cortical button result in good postoperative rom, mepi and qdash scores and strength.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being filed to correct information.

Event Description

Information was received based on review of a journal article titled, "reconstruction of distal biceps tendon ruptures with a cortical button" which aimed to evaluate the results of a cortical button reconstruction technique in patients with a traumatic distal biceps tendon rupture, using the toggleloc, manufactured at (b)(4).This study consisted of 22 patients with 24 traumatic distal biceps tendon ruptures underwent surgical treatment between 2007 and 2010.The median age at time of injury was 49 years and dominant arm was involved in 55% of patients.Before may 2009, the repair was done using a competitor product, and after, the repairs were performed using the toggleloc.The journal article reports the following complications: two (2) cases of dysfunction of the posterior interosseous nerve.One (1) case of symptomatic partial re-rupture of the distal biceps tendon.One (1) case of awareness of the cortical button, resolved by the button being removed.One (1) case of crepitus from heterotrophic ossification.One (1) case of irritation from the fixation sutures of an allograft.One (1) case of an elongated biceps tendon which required a reconstruction.In conclusion, the distal biceps tendon reconstructions with a cortical button result in good postoperative rom, mepi and qdash scores and strength.

• Brand Name: UNKNOWN SPORTS MEDICINE
• Type of Device: FIXATION, FASTENER
• 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: 5563077
• MDR Text Key: 42328095
• Report Number: 0001825034-2016-01190
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN SPORTS MEDICINE
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2016
• 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): Required Intervention