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

Catalog Number 72203852

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the anchor pulled out of the bone hole.A backup device was readily available.There was a delay of less then 30 minutes.No patient injuries were reported.

Manufacturer Narrative

Device investigation narrative - the device, used for a hip procedure, was not returned.The complaint allegation listed three concerns.The first concern was that after pulling the anchored suture, the anchor ¿popped out¿.The second concern was that the suture did not slide properly.The third comment was that there was a knot in the ub suture at the anchor location.The surgeon suspected that the knot was there prior to surgery.The knot was visually confirmed although this knot is an overhand knot that could not have been in the suture during manufacturing or it would have inhibited the loading of the device.The complaint asked to ¿please evaluate and include possible cause of knot sliding defect¿.This request is impossible without a device returned, although it is likely that the knotted suture could have contributed.We have not received any more complaints for this lot with this allegation.No root cause related to the manufacture of this device can be determined.No further investigation warranted.Device returned for evaluation.Date received by manufacturer.Device evaluated by the manufacturer.Evaluation codes updated.

• Brand Name: SUTUREFIX ULTRA AHR S, #2 UB STR, BLUE
• 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: 6667840
• MDR Text Key: 78507230
• Report Number: 1219602-2017-00663
• 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: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2017

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: 72203852
• Device Lot Number: 50589871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 06/26/2017
• Supplement Dates Manufacturer Received: 07/18/2017
• Supplement Dates FDA Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR