MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS, BUTTON, 8 X 12 MM; BIT, DRILL

Model Number	TIGHTROPE ABS, BUTTON, 8 X 12 MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the ar-12990, knee scorpion has a broken needle piece within the device itself that cannot be removed.This occurred during a revision meniscal root repair.The rep stated that there were three scorpion needles used.The first scorpion needle broke upon insertion.The surgeon went to deploy the needle, and a loud audible click occurred.It was then discovered that the needle broke.An x-ray was taken and confirmed that there were not any fragments left in the patient.The second needle bent, and was not firing appropriately.The surgeon dry fired the second needle, and in doing so, there was resistance.Upon dry firing the second needle, it was discovered that the ar-12990, knee scorpion had a broken piece within the device.The surgeon decided to bring in a third scorpion needle and a replacement ar-12990.As the surgeon was getting ready to proceed, the surgeon decided that the patient was not a good candidate for the revision meniscal root repair.Additional information has been requested.Additional information received on 09/05/2018: the rep confirmed that the patient had an acl reconstruction with meniscal root repair on (b)(6) 2018.After the surgery the patient was non-compliant with post-operative care protocol and experienced a fall.Following the fall incident the patient was experiencing pain and went back to his surgeon for follow-up care.During the follow-up visit the surgeon took an x-ray that revealed that the tibial fixation button of the meniscal root repair had moved away from the tibial cortex, indicating a failure of the meniscal root repair.The rep confirmed that ar-1588tb (lot number unknown) was explanted during the revision surgery.During the case the surgeon removed the ar-1588tb from the tibial location of the meniscal root repair, with a mini-open incision.After the surgeon removed the remaining fiber wire sutures within the meniscus arthroscopically, the incident with the ar-12990, knee scorpion and needles occurred.With the patient¿s prior history of being non-compliant with post operative care the surgeon then decided at that time the patient would not be a good candidate for the meniscal root repair.Additional information received on 09/13/2018: the rep confirmed that no meniscal root repair was done.The surgeon decided to perform a partial meniscectomy/meniscal debridement.

• Brand Name: TIGHTROPE ABS, BUTTON, 8 X 12 MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7889008
• Report Number: 1220246-2018-00649
• Device Sequence Number: 14044661
• Product Code: HTY
• UDI-Device Identifier: 00888867019621
• UDI-Public: 00888867019621
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K110123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

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 Model Number: TIGHTROPE ABS, BUTTON, 8 X 12 MM
• Device Catalogue Number: AR-1588TB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 09/19/2018
• 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