MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE 35 DEGREE UP; ACCESSORIES,ARTHROSCOPIC

Catalog Number 7209499

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

It was reported that the jaws of the arthropierce 35deg upbiter opened completely.No pieces broke off inside the patient.There was a reported delay of between 30 and 60 minutes while a backup device could be acquired.It was noted that there was no patient impact as a result of the event.

Manufacturer Narrative

The distal tip has broken at the lug area.The distal tip of the device has also been dramatically bent downward and twisted to the right.The movable jaw is free from the device and was not returned for evaluation.The condition of the device is the result of excessive force being placed on it during use.Excessive force can result in instrument failure.Use error cannot be ruled out as a contributory factor.

• Brand Name: ARTHROPIERCE 35 DEGREE UP
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5980994
• MDR Text Key: 56016555
• Report Number: 1219602-2016-01112
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

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: Health Professional
• Device Catalogue Number: 7209499
• Device Lot Number: 50591607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1