MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MM; WASHER, BOLT NUT

Model Number	IMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/05/2020
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 root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a (b)(6) 2020 procedure while the surgeon was advancing the k-wire from the ar-8914ds (mini tightrope implant system) through the second metacarpal hard bone was encountered and the tip of the k-wire broke off into the metacarpal.After fluoroscopic examination and discussion, the surgeon was forced to leave the tip of the k-wire in the patient's second metacarpal.Additional information obtained 11/16/2020: procedure was a cmc suspensionplasty.Lot number of the k-wire was not recorded.Remaining k-wire was discarded in a sharps box and is not available to return.

• Brand Name: IMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MM
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10934364
• Report Number: 1220246-2020-02377
• Device Sequence Number: 4295251
• Product Code: HTN
• UDI-Device Identifier: 00888867048881
• UDI-Public: 00888867048881
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K090107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/02/2020

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: IMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MM
• Device Catalogue Number: AR-8914DS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/02/2020
• 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