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

Model Number	7207220
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was broken and a fragment remained inside the patient.Kelly forceps in order to remove the fragment.No patient injury was reported.
Additional Manufacturer Narrative
One 7207220 2.4mm 17¿ trocar passing pin returned.There was a portion of an accessory kit returned as well that is not our product.Per the complaint: ¿as reported: the passing pin was placed on the motor, it was passed it through the tibia, and at the moment of removing it a little, the passing pin came out, we saw on the screen that it was broken and a fragment remained inside the patient.We used a kelly forceps in order to remove the fragment.The product was new and it was used according to the corresponding technique.The procedure was completed with another s&n passing pin¿.The instrument is less than one year old.It is used, but in good condition and does not present any obvious damage.There is no bowing, bend or breakage.There are small dings on the tip edges only.There are light scratches at the tip only.These observations would not have produced a broken piece; only a minimal amount of shaving at worst case.There was no stray portion of pin returned.The allegation cannot be substantiated by the device returned.No root cause related to the manufacture of the device can be established.No further investigation is warranted at this time.
Event or Problem Description
It was reported that the device was broken inside the patient and kelly forceps were used to remove the fragment.The procedure was completed with another s&n passing pin.No patient injury was reported.

• 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: 6978124
• Report Number: 1219602-2017-01334
• Device Sequence Number: 1196705
• Product Code: LXH
• UDI-Device Identifier: 03596010375315
• UDI-Public: (01)03596010375315(17)220707(10)50673356
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2017

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 Model Number: 7207220
• Device Catalogue Number: 7207220
• Device Lot Number: 50673356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 66