MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AWL-DILATOR, TWINFIX ULTRA, 4.5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72202633

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the tip of the awl-dilator twinfix ultra 4.5mm broke off while prepping the rotator cuff.The broken tip was reportedly exhausted from the joint via suction.Another inserter was used and the site was prepared without delay or patient harm.

Manufacturer Narrative

Device investigation narrative - examination was not possible, as the device has not been returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event without the return of the device.Further investigation is not warranted at this time.Evaluation codes updated to indicate that manufacturing review was performed.(b)(4).

• Brand Name: AWL-DILATOR, TWINFIX ULTRA, 4.5MM
• 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: 5876014
• MDR Text Key: 53013081
• Report Number: 1219602-2016-00499
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/19/2016

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: 72202633
• Device Lot Number: 50485259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2013
• 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