MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PIN,PASSING,2.4MM TROCAR 17

Model Number	7207220
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the surgery when the device was being inserted the pin was not advancing and smoke came out.The pin was removed in order to see what happened, it was noticed that the pin broke inside the patient.A moderate incision was made in order to remove the broken pieces, all the pieces were removed.Back-up device was used to complete the procedure.
Additional Manufacturer Narrative
Device has not been returned for examination.Photographic evidence was supplied for evaluation.The photo was reviewed and it was confirmed that the passing pin is broken and bent.The passing pin is scored along its length and shows metal debridement at the bend location.It appears that during placement of the passing pin the pin became bent causing it to come in contact with the drill guide resulting in the observed damage and breakage.Drilling with a bent passing pin would require the use of excessive force.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.It has been reported that there is no patient injury involved, and the broken fragment was successfully removed.No relevant supporting clinical information has been provided to assist with a clinical investigation.

• Brand Name: PIN,PASSING,2.4MM TROCAR 17
• Common Device Name: PIN,PASSING,2.4MM TROCAR 17
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7919138
• Report Number: 1219602-2018-01346
• Device Sequence Number: 1913862
• 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
• Report Date (Section B): 11/29/2018

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: 06/25/2023
• Device Model Number: 7207220
• Device Catalogue Number: 7207220
• Device Lot Number: 50743531
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/29/2018
• 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: Other
• Patient Age: 44 YR
• Patient Weight: 108