MAUDE Adverse Event Report: ARTHREX, INC. SPEEDBRIDGE IMPLANT SYSTEM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-2600SBS-5
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/13/2016
Type of Reportable Event	Serious Injury
Additional 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.The evaluation of the returned device revealed the distal end is broken off.No damage or defects were found with the other components.Device history record review revealed nothing relevant to this event.The complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel, prying/levering or impacting the eyelet against hard bone.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 or Problem Description
It was reported that during a shoulder scope, the surgeon was attempting to use the ar-2600sbs-5, speedbridge implant system with bio-composite swivelock.The surgeon was inserting the white threaded swivelock anchor of the implant system.The swivelock anchor was implanted approximately two thirds of the way when the remaining one third of the anchor broke off.The surgeon pulled on the two thirds portion of the anchor that was implanted and felt it was secure and sufficient to complete the procedure.

• Brand Name: SPEEDBRIDGE IMPLANT SYSTEM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6076879
• Report Number: 1220246-2016-00478
• Device Sequence Number: 817821
• Product Code: MAI
• UDI-Device Identifier: 00888867027329
• UDI-Public: 00888867027329
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K101823.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2018
• Device Catalogue Number: AR-2600SBS-5
• Device Lot Number: 10049831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2016
• Initial Report FDA Received Date: 11/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR