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	09/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery when the doctor ask for the device, it came out of the package bent.No patient injury was reported.Back-up device was not available.
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.Further investigation is not warranted at this time.
Additional Manufacturer Narrative
One 2.4 trocar tipped passing pin was returned for evaluation.Visual assessment of the device confirmed the reported complaint of being bent.The passing pin is bent on two planes mid-point of its length.Shelf carton was not returned for examination.During the packaging process these devices are inspected 100%.A defect of this degree would be highly detectable.The damage appears to have happened outside of smith+nephew control.

• 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: 7915007
• Report Number: 1219602-2018-01330
• Device Sequence Number: 11212012
• Product Code: LXH
• UDI-Device Identifier: 03596010375315
• UDI-Public: (01)03596010375315(17)230625(10)50743531
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2019

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: 7207220
• Device Lot Number: 50743531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/16/2018; 01/08/2019
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/17/2018; 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1