MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.4 MM X 17" (43 CM) TROCAR-TIP PASSING PIN (STERILE), SINGLE USE; PASSER, WIRE, ORTHOPEDIC

Catalog Number 7207220

Device Problem Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2013

Event Type  malfunction  

Manufacturer Narrative

Subject device was not received for evaluation.Review of the device history records was performed which confirmed no discrepancies.A complaint history review did not identify additional complaints filed for the manufactured lot on file.Reportedly, there were no internal processing issues that would contribute to the nature of the issue.Per results of the investigation, no root cause could be determined.At this time, no further investigation is warranted.(b)(4).

Event Description

During an anterior cruciate ligament procedure utilizing the 2.4 mm x 17" (43 cm) trocar-tip passing pin (sterile) single use, it was reported that, the passing pin was shedding while the surgeon was drilling into the bone.The joint space was flushed and the flakes were removed with a shaver.It is stated that there was no backup device available, and that the initial device was used to complete the procedure.(b)(4).

• Brand Name: 2.4 MM X 17" (43 CM) TROCAR-TIP PASSING PIN (STERILE), SINGLE USE
• Type of Device: PASSER, WIRE, ORTHOPEDIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4964004
• MDR Text Key: 23401628
• Report Number: 1219602-2015-00678
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 05/29/2013

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
• Device Operator: Health Professional
• Device Catalogue Number: 7207220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1