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	10/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pin passing 2.4mm trocar 17 dropped metal shreds after being passed through the tibia, the traces were removed with the shaver.A second passing pin was used and it also dropped metal shreds when it was passed through the tibia and the femur.No significant delay or patient injury reported.
Additional Manufacturer Narrative
Two 7207220 2.4mm 17¿ trocar passing pins returned.They will be evaluated together.These instruments are used.They are less than one year old.The pins have attained damage.They are bowed and bent.One has been broken.The missing portion was not returned.Visual inspection shows both pins have scoring and skiving on the surface in several locations along the length of the pins.There are dings and chips on the tip of the complete pin.Contact with other instruments or devices have occurred.These symptoms indicate that the pins were used in a challenging manner which produced the shedding.Both have been stressed indicating pressure contributed.No root cause related to the manufacture of the device can be established.

• 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: 6958923
• Report Number: 1219602-2017-01310
• Device Sequence Number: 1364801
• Product Code: LXH
• UDI-Device Identifier: 03596010375315
• UDI-Public: (01)03596010375315(17)220629(10)50672165
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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: 06/29/2022
• Device Model Number: 7207220
• Device Catalogue Number: 7207220
• Device Lot Number: 50672165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 43