MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO, 90 DEGREE STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SUTURELASSO, 90 DEGREE STRAIGHT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by a patient's father that the patient had undergone an arthroscopic labrum repair procedure on (b)(6) 2018.Upon completion of the procedure the patient and his mother were informed that during the procedure, when placing the second arthrex suturetak anchor, the 90 degree suture lasso broke.Surgeon located the device and attempted to retrieve but was unsuccessful.The surgeon continued with the procedure, completing it arthroscopically.The device fragment was left in the labral capsule and was reported to be approximately 1/2 cm in length.Patient's father requested that the facility retain the 90 degree suture lasso instrument for future investigation/evaluation.It is unknown if the device was retained as requested.Additional information obtained 2/13/19: according to additional information provided by the patient¿s father the surgeon stated that he did not want to jeopardize the stability of the shoulder by opening or taking down the labral capsular complex arthroscopically.Post-op x-rays were used to monitor the suture lasso tip.Report further stated that if the suture lasso tip moved, then the surgeon would most likely proceed with a second surgery to remove the device fragment.Additional information received 12/20/2021: according to additional medical records, the patient was a rugby player and had experienced approximately eight episodes of dislocation prior to the original surgery on (b)(6) 2018.The records indicate that on or before (b)(6) 2019, a second arthroscopic surgery was performed at a different facility, by a different surgeon, to remove the retained fragment.During the procedure, the surgeon had to undo the previous labrum repair as the suture lasso fragment was under the labrum.After the fragment was identified and successfully removed the surgeon was able to perform a bankart repair of the labrum using a 3.0 mm biocomposite suturetak anchor and a 2.9 mm peek pushlock anchor.
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: b4, g3, h6.
Additional Manufacturer Narrative
The complaint allegation was not confirmed.The complaint device was not received for evaluation.According to the supplier certificate of conformance, component c4719-01 at revision 1 was pull-tested as per the requirements on drawing c4719 at revision 4.Note 3: wire must withstand a 5lb pull at radius area with force allied at approx.90° in each direction from bend.Based on the information provided, the most likely cause of the reported failure is user error in the device due to excessive force used during suture passing/tightening /tensioning during implant insertion.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(4).

• Brand Name: SUTURELASSO, 90 DEGREE STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 13254152
• Report Number: 1220246-2022-04289
• Device Sequence Number: 11180757
• Product Code: LXH
• UDI-Device Identifier: 00888867031517
• UDI-Public: 00888867031517
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2024

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: SUTURELASSO, 90 DEGREE STRAIGHT
• Device Catalogue Number: AR-4068-90
• Device Lot Number: 824185941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 04/17/2024; 10/04/2024
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 05/09/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male