MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCH BIOCOMP CORK SCREW FT VNTD 5.5X14.7MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1927BCNF

Device Problems Break (1069); Detachment Of Device Component (1104); Crack (1135)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/18/2014

Event Type  Injury  

Event Description

It was reported that during a mini open rotator cuff repair the first attempt using this device on the medial humeral head of the shoulder was unsuccessful as the implant cracked after being placed approximately 2/3 of the way into the bone.The distal end of the implant broke off and remained unretrieved in the patient's bone.Bone preparation for this attempt was done using a bone punch.A second attempt using another of the same device was then made near the same location as the first attempt on medial humeral head.Again, during insertion, the implant cracked after being placed approximately 2/3 of the way into the bone.The distal end of the implant broke off and remained unretrieved in the patient's bone.To complete the case a different style implant was used successfully.The procedure type from the start of the case was a mini open rotator cuff repair.No patient information reported at time of call.

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.The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation revealed that the implants are broken.Proximal sections were returned.Fractures are located approximately between the 4th and 5th proximal threads.Complainant's event typically caused by not inserting the implant co-axial to the bone tunnel or prying/leveraging the driver while the implant is still loaded.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.

• Brand Name: SUTURE ANCH BIOCOMP CORK SCREW FT VNTD 5.5X14.7MM
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 3691873
• MDR Text Key: 19021209
• Report Number: 1220246-2014-00038
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Catalogue Number: AR-1927BCNF
• Device Lot Number: 875265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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