MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAST-FIX 360 KPSC AND SLOTTED CANNULA; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72202674

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).One fast-fix 360 kpsc was returned for evaluation.Visual assessment of the device showed what appears to be human matter on the device.The device was tested with a presumptive blood test kit which confirmed the presence of blood.As reported the complainant alleges the device was contaminated when the package was opened and determined the device was safe for use to complete the procedure.As a result it cannot be determined where or when the device became contaminated.Per the device ifu under precautions ¿prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device¿.After the evaluation the root cause for the reported issue could not be determined.No further investigation is warranted at this time.

Event Description

During a meniscal repair procedure it was reported that when the package was opened it was noticed that the shaft of the device was rusted.The trigger did not move smoothly.The operation was completed with this device.No patient injury reported.It was reported that there was no damage noted to the device or the device packaging.The package containing the device had been completely sealed.The device was not reprocessed, or reused on a patient.The patient was noted to be okay post-procedure.

• Brand Name: FAST-FIX 360 KPSC AND SLOTTED CANNULA
• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5176687
• MDR Text Key: 29882309
• Report Number: 1219602-2015-01097
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2015

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 Expiration Date: 12/12/2019
• Device Catalogue Number: 72202674
• Device Lot Number: 50531072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2015
• Initial Date FDA Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2014
• 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