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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the passing pin broke during use.The broken tip was removed from the patient and a backup device was available to complete the procedure.A short delay was reported with no patient impact.
Additional Manufacturer Narrative
Device investigation narrative - one 2.4mm trocar tipped passing pin was returned for evaluation.Visual assessment of the device confirmed the reported complaint of breakage.Approximately 2 inches of the distal tip has been sheared off.The distal tip is heavily damaged and is missing material.The break area on the shaft is also heavily damaged and missing material.The shaft is bent.The condition of the device indicates that during over-drilling the passing pin became bent causing the drill to come in contact with it resulting in the observed damage.Per the devices ifu under precautions ¿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¿.Further investigation is not warranted at this time.(b)(4).

• 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: 6835955
• Report Number: 1219602-2017-01050
• Device Sequence Number: 13467738
• Product Code: LXH
• UDI-Device Identifier: 03596010375315
• UDI-Public: (01)03596010375315(17)220406(10)50657198
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2017

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: 04/06/2022
• Device Model Number: 7207220
• Device Catalogue Number: 7207220
• Device Lot Number: 50657198
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1