MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP. SUTURE TAK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1934BCF-24

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/29/2016

Event Type  Injury  

Manufacturer Narrative

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 contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.This type of event is typically caused by not inserting the implant coaxial to the bone tunnel, prying/leveraging the driver while the implant is still loaded and/or improper bone preparation prior to insertion.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.Device remains in patient.

Event Description

It was reported that during an orif right elbow coronoid fracture repair, the bio-composite suturetak suture anchor broke on insertion.The surgeon attempted multiple times to remove the anchor but was not able to do so.No patient injury reported.

• Brand Name: BIO-COMP. SUTURE TAK
• 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: 5878365
• MDR Text Key: 52182216
• Report Number: 1220246-2016-00346
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867023901
• UDI-Public: 00888867023901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Catalogue Number: AR-1934BCF-24
• Device Lot Number: 1425395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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
• Patient Age: 57 YR
• Patient Weight: 99