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

Catalog Number	72201594
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during acl procedure, the device broke into the femur.All pieces were removed from patient.There was no delay or patient injuries reported but it is unknown how the procedure was finished since there was no backup device available to complete the procedure.
Additional Manufacturer Narrative
The reported flexible passing pin is intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the device broke during use, causing it to break off in the patient.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive forces applied to the device can result in failure.The instructions for use were reviewed and were 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.
Additional Manufacturer Narrative
Additional information.
Event or Problem Description
It was reported that during acl procedure, the device broke into the femur.All pieces were removed from patient.A back up was available and it was used next to the original hole.No delay or patient injuries were reported.

• 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: 8392857
• Report Number: 1219602-2019-00263
• Device Sequence Number: 18895435
• Product Code: NBH
• UDI-Device Identifier: 03596010601452
• UDI-Public: 03596010601452
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/03/2019

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: 10/07/2021
• Device Catalogue Number: 72201594
• Device Lot Number: 50624546
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 03/14/2019; 04/03/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 03/15/2019; 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR