MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOFEMORAL AIMER, 5MM OFFSET; ACCESSORIES, ARTHROSCOPIC

Catalog Number 72201715

Device Problems Metal Shedding Debris (1804); Scratched Material (3020)

Patient Problem Toxicity (2333)

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown.Subject device(s) were returned for evaluation.Visual inspection did not identify sharp edges that could have contributed to the reported failure mode of ¿shedding/flaking¿.Examination of the aimers showed a small burr which may have contributed to the complained issue.Per the instructions for use (ifu), ¿ prior to use inspect the device to ensure it is not damaged.Do not use a damaged device¿.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.Per results of the investigation, the root cause is ¿improper maintenance¿.At this time, no further investigation will be implemented.(b)(4).

Event Description

During an anterior cruciate ligament (acl) reconstruction procedure utilizing the universal endoscopic handle, it was reported that the guide wires were being scratched by the endo femoral guides and/or handle.It was reported that there were metal shavings noticed inside of the patient.Sales representative states that the surgeon may not have been keeping the guide wires parallel to the guide causing friction.This friction would cause abrasions and metal shedding/flaking.It was reported that the metal shavings were removed by flushing/irrigation and suctioning of the site in order to remove all particulate from patient.It was reported that a backup device was available.(b)(4).

• Brand Name: ENDOFEMORAL AIMER, 5MM OFFSET
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: 5091796
• MDR Text Key: 26349375
• Report Number: 1219602-2015-01020
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 09/24/2013

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
• Device Operator: Health Professional
• Device Catalogue Number: 72201715
• Device Lot Number: 50414561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention