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

Model Number	7207220
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery, when the doctor passed the guide (2.4 mm), the guide started to release some particles of the material that is made and these were inside the patient.Some particles were cleaned, but some of them remained inside the patient (there were too small).There was no significant delay or patient injuries.
Additional Manufacturer Narrative
Examination is not possible, as the device has not been returned, however photographs were sent for evaluation.Review of the photographs confirmed the reported complaint of shedding.The photos show a guide wire that is heavily scored in a circular manner missing material.An exact root cause cannot be determined with confidence without the return of the device.Further investigation is not warranted at this time.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.

• 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: 7776292
• Report Number: 1219602-2018-01038
• Device Sequence Number: 1757429
• Product Code: LXH
• UDI-Device Identifier: 03596010375315
• UDI-Public: (01)03596010375315(17)230605(10)50739645
• 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): 12/19/2018

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: 06/05/2023
• Device Model Number: 7207220
• Device Catalogue Number: 7207220
• Device Lot Number: 50739645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 09/19/2018; 12/18/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 09/20/2018; 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1