MAUDE Adverse Event Report: ARTHREX INC. RKSCREW FT, PEEK, SUTURETAPE, 4.75M; SCREW, FIXATION, BONE

Catalog Number	AR-1927PST-475
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation 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.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a rotator cuff repair while implanting the device; the surgeon tapped and punched as he was supposed to and the anchor body collapsed.The suture eyelet came out of the anchor body and the distal end collapsed completely.The anchor held on to the eyelet but the distal end shattered.Surgeon tested to make sure it was going to hold and it did.Surgeon then passed the suture through the cuff and it held and then proceeded as normal.Then proceeded and implanted a lateral anchor.The procedure was completed successfully.The quality of the bone was hard.Follow-up investigation: the distal end of the corkscrew anchor had collapsed/compressed.When this occurred the eyelet became slightly loose but remained attached to the anchor.The surgeon chose to leave the whole anchor with the collapsed/compressed distal end in place since it was holding tight and continued to complete the procedure with this corkscrew anchor.No additional unplanned incisions or anchors were needed.

• Brand Name: RKSCREW FT, PEEK, SUTURETAPE, 4.75M
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7380853
• Report Number: 1220246-2018-00110
• Device Sequence Number: 1103707
• Product Code: HWC
• UDI-Device Identifier: 00888867237872
• UDI-Public: 00888867237872
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

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: 04/01/2022
• Device Catalogue Number: AR-1927PST-475
• Device Lot Number: 10140123
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/29/2018
• 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