MAUDE Adverse Event Report: ARTHREX, INC. TENODESIS SCREW, PEEK; SCREW, FIXATION, BONE

Model Number	TENODESIS SCREW, PEEK
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/23/2018
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 not returned for evaluation.The device was reported to have been discarded by the facility.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 a revision surgery took place ((b)(6) 2018) for a failed interosseous sl reconstruction that took place on (b)(6) 2018.The rep stated that the patient was feeling pain and instability post-surgery.X-rays revealed that the ar-8978p (lot: f192202) originally implanted on 05/21/18 was no longer in the bone and floating in the joint causing the whole construct to fail.The surgeon decided to remove the proximal row of carpal bones in fear of another failure.After removing the anchor from the joint, it was noticed that the tip of the ar-8978p was bent.All other original implanted devices remained in the bone, and the bone was completely removed from the patient¿s body.No other arthrex parts were implanted during the revision surgery.Additional information has been requested.Additional information received 07/29/2018: the rep confirmed that the original surgery and revision surgery took place at the same facility.The patient was an older female.The exact age of the patient is unknown.The rep confirmed that the following arthrex parts were implanted in the original surgery on (b)(6) 2018, and all were explanted during the revision surgery on (b)(6) 2018.The surgeon elected to do a proximal row carpectomy and thus all implants were then explanted in the process.Ar-1530ps: lot#: 858862 / quantity: 1.Ar-8978p: lot#: f192202 / quantity: 2.The rep confirmed one ar-8978p (lot: f192202) was explanted before removal of the bones due to it no longer being in bone and floating in the joint.The second ar-8978p (lot: f192202) and ar-1530ps (lot: 858862) were still in the bone when the bones were removed.

• Brand Name: TENODESIS SCREW, PEEK
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7788213
• Report Number: 1220246-2018-00597
• Device Sequence Number: 19154367
• Product Code: HWC
• UDI-Device Identifier: 00888867018662
• UDI-Public: 00888867018662
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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: 11/30/2018
• Device Model Number: TENODESIS SCREW, PEEK
• Device Catalogue Number: AR-1530PS
• Device Lot Number: 858862
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/16/2018
• 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