MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPOSITE P-LOCK 2.9 X 15.5 MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1923BC

Device Problems Break (1069); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/20/2017

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.The devices met all material specifications as received.The evaluation revealed bent and broken tip on one returned device.Device history record review revealed nothing relevant to this event.The complainant's event is typically caused by prying/leveraging the driver.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.

Event Description

It was reported that during a shoulder stabilizing procedure, the tip of device broke during surgery and remains in patient's shoulder.Surgeon tried to retrieve fragment, however, was not successful.Surgery was completed using a biofastak, same surgical technique.Copy of surgical report requested, however, not received.No other event details received.

• Brand Name: BIO-COMPOSITE P-LOCK 2.9 X 15.5 MM
• 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: 6520190
• MDR Text Key: 73665074
• Report Number: 1220246-2017-00135
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10888867023014
• UDI-Public: 10888867023014
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101679
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: AR-1923BC
• Device Lot Number: 1295660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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