MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX ULTRA AHR S, W/2 UB STR #1, BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT

Catalog Number 72203854

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 07/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a revision surgery was performed due to the suturefix ultra ahr s had pulled out of the site approximately nine months post-op.

Manufacturer Narrative

Approximately 1.5 inches of the suture construct and a separate piece of blue ultrabraid suture approximately 1.75 inches long from a suturefix ultra ahr xl was returned for evaluation.Due to the sample size testing of the suture is prohibitive.Visual assessment of the construct showed no defects in the suture that would have contributed to the reported complaint.A review of the device history records and quality records associated with these manufactured lots confirmed that no additional complaints have been filed and that no abnormalities were reported with these product lots during manufacture.A complete medical assessment cannot be provided based on the limited information received; however, the manufacturer is unable to rule out a procedural variance as a contributing factor to the event.

• Brand Name: SUTUREFIX ULTRA AHR S, W/2 UB STR #1, BL
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT
• 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 w william cannon dr; austin, TX 78735 ; 5123585706
• MDR Report Key: 5954282
• MDR Text Key: 54875945
• Report Number: 1219602-2016-00619
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2020
• Device Catalogue Number: 72203854
• Device Lot Number: 5054295
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR