MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH,SCSR,STR; ACCESSORIES, ARTHROSCOPIC

Catalog Number 012036

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 12/05/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(6).An evaluation of the device confirmed that the cutting edge/ distal tip of shaft have broken off.An examination of the break area with the use of a stereo microscope confirmed no material voids.Without the return of the cutting edge we cannot determine a root cause for the failure of this device.No root cause related to the manufacture of the device can be established.No further investigation is warranted at this time.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

The lower jaw of the device broke off inside the patient when the surgeon tried to take a bite of tissue through reasonable use.He retrieved the broken part from the joint with some graspers.No patient injury or other complications were reported.

• Brand Name: PCH,SCSR,STR
• 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: 5963375
• MDR Text Key: 55451745
• Report Number: 1219602-2016-00714
• 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: Other
• Type of Report: Initial
• Report Date: 12/06/2013

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: Other
• Device Catalogue Number: 012036
• Device Lot Number: 50136225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2013
• Initial Date FDA Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1