MAUDE Adverse Event Report: ARTHREX, INC. SPEEDBRID IMP SYS W/ BIO COMP SVELOCK 4.75X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-2600SBS-4

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/09/2014

Event Type  Injury  

Event Description

It was reported that both proximal anchors cracked after a few threads were inserted, then crumbled to pieces after just about half the anchor was inserted.The broken fragments were retrieved but the tips of the two broken anchors remain threaded into the humerus.Rotator cuff repair.Follow-up: about half of the distal end of the screw remained implanted in the bone.The surgeon felt the fixation was good therefore no additional implants were inserted.There have been no further issues reported related to this incident.

Manufacturer Narrative

Patient demographics (date of birth, 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.Only unused kits were returned.The device was requested for evaluation but was not returned 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.If additional relevant information is received, a follow-up report will be submitted.Complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel 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.Only un-opened similar devices returned.

• Brand Name: SPEEDBRID IMP SYS W/ BIO COMP SVELOCK 4.75X19.1MM
• 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: 4234159
• MDR Text Key: 4973960
• Report Number: 1220246-2014-00214
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• 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-2600SBS-4
• Device Lot Number: 1183329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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
• Patient Age: 55 YR