MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP S-TAK 2.4X 12MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1934BCF-24-2

Device Problems Loose or Intermittent Connection (1371); Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 07/17/2015

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.No device malfunction identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Additional information has been requested but not made available.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Unknown device evaluation.

Event Description

It was initially reported that the "measure of the drill doesn't fit to the reference ar-1934d-24".This was observed during a bankart surgery on (b)(6) 2015.Surgeon used three suture tak implants for the surgery.Two of them failed and have been replaced by two implants from another manufacturer during a revision surgery.Follow-up investigation: it was reported that patient had three surgeries in total: first surgery: before (b)(6) 2014 (we don't know the exact date) the surgeon did a shoulder instability surgery (bankart) with products from a different manufacturer and this was unsuccessful, the implants became loose.- no arthrex devices involved in this first surgery.Second surgery: in (b)(6) 2015, revision surgery was performed, for shoulder instability with bankart technique with the following arthrex products implanted: 1x ar-1934bcf-24, lot # 1145407 and 1x ar-1934bcf-24-2, lot# 119080.Implants did pull out of bones.Third surgery: the surgeon did latarjet technique and replaced the arthrex implants with new arthrex implants.Now the patient is pending for post-operative evaluation.

• Brand Name: BIO-COMP S-TAK 2.4X 12MM
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6105410
• MDR Text Key: 59976916
• Report Number: 1220246-2016-00506
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Catalogue Number: AR-1934BCF-24-2
• Device Lot Number: 1190800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other