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

Device Problems Loose or Intermittent Connection (1371); Unstable (1667); Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 07/23/2018

Event Type  Injury  

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 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: DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 7788214
• MDR Text Key: 117259192
• Report Number: 1220246-2018-00596
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867193925
• UDI-Public: 00888867193925
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
• Device Catalogue Number: AR-8978P
• Device Lot Number: F192202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other