MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH,OVAL,UPBRT,15D; ACCESSORIES, ARTHROSCOPIC

Catalog Number 7207200

Device Problem Detachment Of Device Component (1104)

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

Event Date 03/23/2016

Event Type  malfunction  

Manufacturer Narrative

A visual inspection of the device showed the fingerloop and fulcrum are free from the thumbloop confirming the reported disassembly.The fulcrum spring is missing.A dimensional inspection of the handle components confirmed they met print specifications.In order to remove the fingerloop from the thumbloop the fulcrum must be depressed.It appears that the fulcrum was inadvertently depressed causing the disassembly.No root cause related to the manufacture of the device can be established.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

It was reported that the oval punch, upbiter, 15deg handle fell apart during the procedure.No patient injury or other complications were reported.

• Brand Name: PCH,OVAL,UPBRT,15D
• 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: 5974088
• MDR Text Key: 55825652
• Report Number: 1219602-2016-00961
• 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: 03/29/2016

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: 7207200
• Device Lot Number: L50576087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1