MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR,BIO-CORKSCREW, FT, VENTED; SCREW, FIXATION, BONE

Catalog Number	AR-1927BNF
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/23/2016
Type of Reportable Event	Serious Injury
Additional 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 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.Device history record review revealed nothing relevant to this event.Based on the information provided, the most likely cause(s) of this event include improper bone preparation for the hardness of bone encountered, not inserting the implant co-axial to the bone tunnel, prying/leveraging the driver while the implant is still loaded, and/or over-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.Unknown device disposition.
Event or Problem Description
It was reported via a medwatch letter (mw5063409) that the following was reported: a patient underwent a repair of a shoulder rotator cuff tear and while the surgeon was screwing the suture anchor in place, the implant broke.Approximately half of the implant remained in the patient shoulder.Per the medwatch report the surgeon determined that fixation of the implant was okay and removal was unnecessary.The medwatch did not include facility name, address or contact information.Therefore, no additional information could be obtained.

• Brand Name: SUTURE ANCHOR,BIO-CORKSCREW, FT, VENTED
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5895822
• Report Number: 1220246-2016-00334
• Device Sequence Number: 13571189
• Product Code: HWC
• UDI-Device Identifier: 00888867023505
• UDI-Public: 00888867023505
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2016

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: 04/01/2017
• Device Catalogue Number: AR-1927BNF
• Device Lot Number: 1239123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2016
• Initial Report FDA Received Date: 08/23/2016
• 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