MAUDE Adverse Event Report: ARTHREX, INC. AC TIGHTROPE REPAIR KIT, TITANIUM; WASHER, BOLT NUT

Model Number	AC TIGHTROPE REPAIR KIT, TITANIUM
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, it cannot be determined how the device may have caused or contributed to the patient¿s experience.An evaluation of the device cannot be performed as the device was expected but has not returned to arthrex.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that during an ac repair with ac tight rope the blue sutures failed to tension.A revision surgery was performed on the (b)(6) 2018.
Additional Manufacturer Narrative
Unable to confirm the event as described.The evaluation revealed no damage or anomaly that would have contributed to the reported issue.The suture appeared to be threaded correctly through the oblong button.The device had been cut apart and the various components were saturated with dried biological material, which prevented further testing.

• Brand Name: AC TIGHTROPE REPAIR KIT, TITANIUM
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7624595
• Report Number: 1220246-2018-00511
• Device Sequence Number: 1788432
• Product Code: HTN
• UDI-Device Identifier: 00888867026391
• UDI-Public: 00888867026391
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K052776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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: No Information
• Device Model Number: AC TIGHTROPE REPAIR KIT, TITANIUM
• Device Catalogue Number: AR-2257
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 08/20/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other