MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX ULTRA AHR S, #2 UB STR, CB BLU; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72203853

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 12/07/2017

Event Type  Injury  

Event Description

It was reported that during procudure, the anchor was implanted to site properly.When a shaft removed from site, suture cut off.The anchor was remained in the site.Therefore, new site was drilled and implanted backup device and completed the procedure.Then, the metal piece was found in x-ray check at post operation.The surgeon decided to remove remaining metal piece/anchor and it was removed.Two hours extension was reported.

Manufacturer Narrative

One suturefix ultra ahr s was returned for evaluation.Visual assessment of the device could not confirm the reported breakage of the suture as no suture was returned for examination.Breakage of the distal end of the fork was confirmed.One of the fork tines has broken off and was not returned.There is a slight twist at the break area.The handle is broken and it was reported that the surgeon broke the handle to observe the fork damage.The condition of the fork indicates it was rotated/torqued during use.It is recommended that once seated, do not rotate the suture anchor device in the bone as this may cause device failure.

• Brand Name: SUTUREFIX ULTRA AHR S, #2 UB STR, CB BLU
• 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: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7145439
• MDR Text Key: 95720119
• Report Number: 1219602-2017-01587
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554031447
• UDI-Public: (01)00885554031447(17)220913(10)50684459
• 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: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

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: 09/13/2022
• Device Model Number: 72203853
• Device Catalogue Number: 72203853
• Device Lot Number: 50684459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2017
• 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: 30 YR