MAUDE Adverse Event Report: ARTHREX INC. BIO-COMPOSITE SWIVELOCK SP 5.5X24.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Lot Number	400935
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/17/2017
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.The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation revealed that the screw was broken.The screw's threads had minor gouges and dents.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 causes of this event are being 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 the patient underwent a rotator cuff repair procedure on (b)(6) 2017.On the 2nd.Week post-op follow up appointment, an x-ray confirmed that the metal tip of the device had backed out of the patient's bone.A revision surgery was scheduled and completed on (b)(6) 2017.Upon entering the surgical site, the surgeon realized that the bio-composite swivelock anchor was shattered.All fragments of the anchor were removed with a grasper and was replaced with fibertape and the surgeon did a bone tunnel with a prolene mesh when tying over the bone.The rep noted that the patient's bone was brittle.Patient is a female, (b)(6).Follow-up investigation: the ar-2323bcm is a bio-composite anchor that is self punching and has a metal tip.All broken pieces were retrieved during the revision and are being returned to arthrex for evaluation.No fall or patient injury was reported prior to the post op x-ray.

• Brand Name: BIO-COMPOSITE SWIVELOCK SP 5.5X24.5MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7014199
• Report Number: 1220246-2017-00429
• Device Sequence Number: 19146412
• Product Code: MAI
• UDI-Device Identifier: 00888867026735
• UDI-Public: 00888867026735
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

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: 09/01/2017
• Device Lot Number: 400935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 11/09/2017
• 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: 76 YR