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

Model Number	7207220
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl procedure, the passing pin had a high metal abrasion.Fragments felt inside the patient but were removed with a shaver.The procedure was successfully completed without significant delay using the same device.No 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
One 7207220 pin passing 2.4mm trocar 17 was returned for evaluation.The information provided states: ¿during an acl procedure, the passing pin had a high metal abrasion¿.Visual assessment showed confirms complaint.The passing pin showed flaking.A fragment was returned.An exact root cause cannot be determined with confidence factors that could have contributed to the reported event include: excessive force.Ifu states: ¿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¿.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.No further investigation is warranted.

• Brand Name: PIN PASSING 2.4MM TROCAR 17
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10491644
• Report Number: 1219602-2020-01356
• Device Sequence Number: 14175322
• Product Code: LXH
• UDI-Device Identifier: 03596010375315
• UDI-Public: 03596010375315
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2024
• Device Model Number: 7207220
• Device Catalogue Number: 7207220
• Device Lot Number: 2038838
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention