MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE PASSING PIN 13.50 X 2.4MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72201594
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the passing pin was breaking in half.The procedure was successfully completed without delay using a back-up device.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.H3, h6: the reported 13.50 x 2.4mm flexible passing pins (4), used in treatment, were returned for evaluation.Three additional unused passing pins were also returned.Visual assessment of the used passing pins confirmed the reported breakage.Approximately 1.5 inches of the distal end of each passing pin has broken off and were returned.There are no material voids present at the break area.Each of the passing pins are bent to varying degrees, one is dramatically bent, this pin is also heavily scored at the broken tip and proximal end.Dimensional assessment of the guidewires diameter was found to meet print specification.The condition of the guidewires indicates they were subjected to excessive forces during use resulting in the reported failure.Per the device instructions for use under ¿precautions¿ as with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in failure.A review of the manufacturing and complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.The report numbers of the three other mentioned devices are: 1219602-2020-00131, 1219602-2019-01534 and 1219602-2020-00132.
Additional Manufacturer Narrative
H6: the reported flexible passing pin, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the passing pin broke during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied to the passing pin during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: FLEXIBLE PASSING PIN 13.50 X 2.4MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9443037
• Report Number: 1219602-2019-01537
• Device Sequence Number: 16650642
• Product Code: NBH
• UDI-Device Identifier: 03596010601452
• UDI-Public: 03596010601452
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2020

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: 05/30/2022
• Device Model Number: 72201594
• Device Catalogue Number: 72201594
• Device Lot Number: 50666586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 01/13/2020; 03/27/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/14/2020; 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1