MAUDE Adverse Event Report: ARTHREX, INC. DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/29/2019
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 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 a patient underwent a scapholunary ligament reconstruction on (b)(6) 2017 due to a scapholunar dissociation.The surgery was performed with an arthrex reconstruction set (internal brace) augmented with ecrl tendon strips, transfixation with k-wire.The patient had good joint cartilage conditions at this time.After the first surgery, the patient suffered from persistent discomfort and renewed dissociation as well as the development of large lysis zones in the area of the screw anchorage of the ligament reconstruction.In a ct performed on the patient, only a radioulnar partially intact joint space was visible.The doctor decided to perform a revision surgery on (b)(6) 2019.When the anchors were removed, one was broken and the other was loose, causing them to grind and damage the cartilage in the radiocarpal joint.The tape showed itself prominently in the joint.The patient received a wrist stiffening due to the incident because the cartilage and bone were so seriously destroyed that a joint-preserving intervention with partial arthrodesis was no longer possible.Due to the arthrodesis of the wrist, the patient can no longer move the wrist.

• Brand Name: DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8381688
• Report Number: 1220246-2019-00923
• Device Sequence Number: 1651064
• Product Code: MBI
• UDI-Device Identifier: 00888867287105
• UDI-Public: 00888867287105
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K150648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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: 06/30/2022
• Device Model Number: DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
• Device Catalogue Number: AR-8978P-1
• Device Lot Number: 10151319
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other