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

Model Number 72203854

Device Problem Bent (1059)

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

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

Zip code: (b)(6).

Event Description

It was reported that the surgeon noted that as he advanced 1st suturefix anchor through guide handle, a lot of resistance felt.Asked the surgeon to pull out anchor and noted that suturefix anchor was bent/disfigured.Opened another drill, 2nd anchor used, same technique utilised.Anchor went in fine.3rd anchor opened, same technique used.Suturefix anchor again bent as being advanced into drill guide.Asked nurse to clean tip of drill, surgeon re drilled, and tried to use same anchor.Advised not to, as anchor already bent.Opened a 4th anchor and followed same steps as per surgical technique.This time anchor went in without any other incident.No patient injury was reported.

Manufacturer Narrative

Examination is not possible, as the device will not be returned.The investigation could not draw any conclusions about the reported event without the return of the device.

• Brand Name: SUTUREFIX ULTRA AHR S, W/2 UB STR #1, BL
• 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: 7366759
• MDR Text Key: 103586668
• Report Number: 1219602-2018-00362
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554030044
• UDI-Public: (01)00885554030044(17)221207(10)50701676
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2022
• Device Model Number: 72203854
• Device Catalogue Number: 72203854
• Device Lot Number: 50701676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2017
• 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