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

Model Number	7210423
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
H10: 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.Further investigation is not warranted at this time.

• Brand Name: ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9519729
• Report Number: 1219602-2019-01628
• Device Sequence Number: 18966439
• Product Code: LXH
• UDI-Device Identifier: 03596010534446
• UDI-Public: 03596010534446
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2020

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 Expiration Date: 04/26/2022
• Device Model Number: 7210423
• Device Catalogue Number: 7210423
• Device Lot Number: 50802116
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 02/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1