MAUDE Adverse Event Report: ARTHREX, INC. SWVLK PEEK TENO 7MM W/FORK EYELET; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SWVLK PEEK TENO 7MM W/FORK EYELET
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament reconstruction surgery the implant was loose after tightening, did not hold in bone.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The contribution of the device to the reported event has yet to be determined.Should additional information be made available, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h6.The complaint allegation was confirmed.One unpackaged ar-1662psl-7-1 batch 15050225 was received for investigation.The returned device was visually inspected, and it was noted that the bio and the eyelet are no longer attached to the device.No visual issue was observed.The attached picture shows that the anchor was returned with the suture.However, these were not received for evaluation.Because of the picture's angle, it is impossible to evaluate the anchor.Functional testing of the driver's outer sleeve and the inner member molded swivelock found that the devices smoothly engaged.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.According to dfu-0087-13 at revision 0, the most likely cause of the reported failure is a use error.G.Precautions.3.Make sure to use the recommended drill bit or punch to create the bone socket.Implant system, tenodesis screw eyelet, and pushlock tenodesis anchor only: under insertion of the device may leave.The proximal end of the implant protruding beyond the cortical bone, which could potentially cause soft tissue irritation and/or pain post-operatively.10.Implant system, tenodesis screw eyelet only: ensure that the eyelet post is securely engaged into the end of the tenodesis driver and held in place by tensioning the fibertape towards the driver handle before inserting into the prepared bone socket.

• Brand Name: SWVLK PEEK TENO 7MM W/FORK EYELET
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: emily shafer ; 8009337001
• MDR Report Key: 17890339
• Report Number: 1220246-2023-08100
• Device Sequence Number: 20720762
• Product Code: MAI
• UDI-Device Identifier: 00888867235717
• UDI-Public: 00888867235717
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SWVLK PEEK TENO 7MM W/FORK EYELET
• Device Catalogue Number: AR-1662PSL-7-1
• Device Lot Number: 15050225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/08/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown