MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 7210423

Device Problem Failure to Eject (4010)

Patient Problem Rupture (2208)

Event Date 11/28/2019

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure, an accu-pass left 45 ° was used to pass the suture points of the anchor in the "labrum" tissue.When the point was passed, the accu-pass was rolled so that the monofilament came out, it was recovered but when pulling it, only half came out because it was locked and it did not advance anymore.When trying to remove the accu-pass from the tissue without the monofilament, the tissue was torn and an anchor point was lost.The procedure was successfully completed using a back-up device.It is unknown if there was any delay as a result of the device malfunction.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: one 7210423 accu-pass str shuttle 45 deg lft curve used in treatment was returned for evaluation.Visual assessment confirms the complaint.The information provided states that ¿that during a surgical procedure, an accu-pass left 45 ° was used to pass the suture points of the anchor in the "labrum" tissue.When the point was passed, the accu-pass was rolled so that the monofilament came out, it was recovered but when pulling it, only half came out because it was locked and it did not advance anymore.When trying to remove the accu-pass from the tissue without the monofilament, the tissue was torn and an anchor point was lost¿.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include improper use of device.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.¿ rolling the wheels forward and backward may initiate tangling or wrapping of the monofilament around the wheels.The roller wheels perform best with continuous movement in the same direction.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of the complaint and manufacturing records was performed and indicated similar allegations for the lot number reported.

Manufacturer Narrative

H3,h6: the accu-pass str shuttle 45 deg lft curve p/n 7210423 was not returned for evaluation.Without the reported product, a visual and functional evaluation cannot be performed and the customer¿s complaint cannot be confirmed.The information provided states that ¿that during a surgical procedure, an accu-pass left 45 ° was used to pass the suture points of the anchor in the "labrum" tissue.When the point was passed, the accu-pass was rolled so that the monofilament came out, it was recovered but when pulling it, only half came out because it was locked and it did not advance anymore.When trying to remove the accu-pass from the tissue without the monofilament, the tissue was torn and an anchor point was lost¿.An exact root cause cannot be determined with confidence; however factors that could have contributed to the reported event include: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device¿.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was preformed, similar complaints of this failure mode were found.

• Brand Name: ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9519676
• MDR Text Key: 173176363
• Report Number: 1219602-2019-01627
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010534446
• UDI-Public: 03596010534446
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2022
• Device Model Number: 7210423
• Device Catalogue Number: 7210423
• Device Lot Number: 50802116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Date Manufacturer Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1