MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA 5.5MM W/3 UB; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72202897

Device Problems Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); No Consequences Or Impact To Patient (2199)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a revision surgery was performed for rotator cuff repairing.(first surgery (b)(6) 2015 - revision (b)(6) 2015.) the revision was performed due to the implant loosening and subsequent tear of the rotator cuff.Any long term ramifications to the patient are unknown.

Manufacturer Narrative

Three requests were made for the return of the device without any response.Should the device be received the complaint will be reopened.A review of the device history records and quality records associated with this manufactured lot confirmed that no additional complaints have been filed and that no abnormalities were reported with this product during manufacture.No further investigation is warranted at this time.(b)(4).

Manufacturer Narrative

Device investigation narrative - one 5.5 twinfix ultra ti anchor was returned for evaluation.Visual assessment of the anchor showed no abnormalities.Dimensional assesment of the anchor confirmed it met all print specifications.This investigation could not identify any evidence of product contribution to the reported incident.Based on this investigation, the need for corrective action is not indicated.(b)(4).

• Brand Name: TWINFIX ULTRA 5.5MM W/3 UB
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5386525
• MDR Text Key: 36685279
• Report Number: 1219602-2016-00041
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K100159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Catalogue Number: 72202897
• Device Lot Number: 50550117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2015
• Initial Date FDA Received: 01/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/05/2016; 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR