MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PIN,PASSING,2.4MM TROCAR 17; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7207220
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that doctor performed the arthroscopy and he started to repair the acl.He put the guide in c on the tibial side and it was put it in the corresponding part, the motor with the 2.4 guide was passed, doctor passed it through the guide in c, the guide was removed and the drill for the femur was passed according to the diameter of the graft.They were starting to pass the drill when the guide of 2.4 was broken, leaving a piece inside the bone, one hour was necessary to remove the broken piece, finally all the piece was removed from the patient.No patient injury was reported.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.No further actions pursued at this time.If objective evidence, relevant information, package or product becomes available to assist with evaluation, the complaint will certainly be revisited.
Additional Manufacturer Narrative
One 7207220 2.4 x 432mm (17¿) trocar passing pin returned.The complaint stated: ¿as reported: we started surgery, doctor performed the arthroscopy and he started to repair the acl.He put the guide in c on the tibial side and i put it in the corresponding part, then i passed the motor with the 2.4 guide, he passed it through the guide in c, the guide was removed and the drill for the femur was passed according to the diameter of the graft.We were starting to pass the drill when the guide of 2.4 was broken, leaving a piece inside the bone, one hour was necessary to remove the broken piece, finally all the piece was removed from the patient.¿ this is a single use passing pin instrument.The pin has severed into two segments.Visual inspection shows the length of the pin portion has a clean shear cut as if by saw, drill or other extremely strong and sharp instrument.There is blackened or ash-like burnt and bio matter attached to the cut portion.Per ifu: ¿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¿.No root cause related to the manufacturing of this device was confirmed.

• Brand Name: PIN,PASSING,2.4MM TROCAR 17
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7858545
• Report Number: 1219602-2018-01220
• Device Sequence Number: 1567497
• Product Code: LXH
• UDI-Device Identifier: 03596010375315
• UDI-Public: (01)03596010375315(17)230625(10)50743530
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2018

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: 06/25/2023
• Device Model Number: 7207220
• Device Catalogue Number: 50743530
• Device Lot Number: 50743530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/22/2018; 11/15/2018
• Initial Report FDA Received Date: 09/08/2018
• Supplement Report FDA Received Date: 10/23/2018; 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1