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

Model Number	72201594
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl repair procedure, when femoral bone hole prep, pin broke off at 4mm from tip.The broken tip was retrieved from patient.No patient injury, but 60 minutes delay was reported.A backup device was available to complete the procedure.
Additional Manufacturer Narrative
Visual assessment of the device confirmed the reported breakage.Approximately.803 of the distal tip has been broken off.Examination of the break area showed no material voids.The broken portion is bent at the break area.The break area is heavily scored in a circular manner which extends proximal to the break.The pin is bowed.The condition of the device indicates it was subjected to excessive force during use.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.

• 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: 7774554
• Report Number: 1219602-2018-01032
• Device Sequence Number: 19281005
• Product Code: NBH
• UDI-Device Identifier: 03596010601452
• UDI-Public: (01)03596010601452(17)220911(10)50684454
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

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: 09/11/2022
• Device Model Number: 72201594
• Device Catalogue Number: 72201594
• Device Lot Number: 50684454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR