MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CUFF STITCH,180 DEG LEFT; ACCESSORIES, ARTHROSCOPIC

Catalog Number 7209161

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

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

Event Date 10/24/2013

Event Type  malfunction  

Manufacturer Narrative

Postal code (b)(6).The device was returned for evaluation for a broken tip.The device and the broken piece were both received.When held back together, it was noted that there was no material missing.The break is located at the transition to the curve.Under stereo magnification, there were no voids in the material.The break shows signs of plastic deformation.In addition, the shaft is bent in a degree opposite the distal curve bend.No root cause related to the manufacturer 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

The tip broke off during a shoulder arthroscopy utilizing the cuff stitch, 180 deg left.The surgeon was going through the anchor铠thread on tendon and broke the instrument within the patient's shoulder.The broken piece was removed from the patient.No patient injury or other complications were reported.

• Brand Name: CUFF STITCH,180 DEG LEFT
• 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: 5963632
• MDR Text Key: 55570957
• Report Number: 1219602-2016-00716
• 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: 12/17/2013

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: 7209161
• Device Lot Number: 50293346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2013
• Initial Date FDA Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR