MAUDE Adverse Event Report: ARTHREX, INC. CIO-COMPOSITE SWIVELLOCK SELF PUNCHING, 4.75 X 24.5 MM; FASTENER, FIXATION, BIODEGRADFABLE, SOFT TISSUE

Catalog Number	AR-2324BCM
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/22/2017
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.Facility name, address or facility contact was not provided and follow up was not possible.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.No new trend, risk, hazard or harm has been identified from the complaint history review.The catalog number, ar-2324bcm and lot number 100780777, associated with this event has been involved in recall number 1220246-4/04/17-001-r.The information received regarding the event is not sufficient to determine the cause of the event or whether it had any relation to the recall.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
During monthly maude review the following incident was discovered reported by the facility (report number mw5069183): during a right rotator cuff repair, the tip of an arthrex suture anchor, biocomposite swivel lock sp self punching 4.75 x 24.5 mm broke off.Unsure if retrieved complete intact tip.The maude report did not contain any facility information or reporter contact information.Follow up not possible.

• Brand Name: CIO-COMPOSITE SWIVELLOCK SELF PUNCHING, 4.75 X 24.5 MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADFABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6662789
• Report Number: 1220246-2017-00220
• Device Sequence Number: 19036705
• Product Code: MAI
• UDI-Device Identifier: 10888867026862
• UDI-Public: 10888867026862
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/23/2017

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: 11/01/2018
• Device Catalogue Number: AR-2324BCM
• Device Lot Number: 10078077
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1220246-4/04/17-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other