MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX UL ANR XL W/1 #2 ULTRABRIAD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72203841

Device Problem Device Slipped (1584)

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

Event Date 12/21/2015

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: zip: (b)(6).(b)(4).

Event Description

It was reported that during a hip arthroscopy/labral repair the surgeon twisted the first anchor in the drill hole before deploying.The anchor discharged as normal, but failed to hold.The second anchor was placed (without twisting) and deployed per technique.Anchor held at first check then pulled out on second check.Third and fourth anchors both worked.The two drilled holes were left with no anchors inserted.No long term ramifications to the patient were reported.

Manufacturer Narrative

Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was performed which confirmed no inconsistencies.No further investigation is warranted at this time.

Manufacturer Narrative

Device investigation narrative - two suturefix assemblies were returned for evaluation.Visual assessment of sample (1) shows the trigger has been advanced to the proximal end on the handle body indicating a complete deployment.The trigger was moved back to the pre-deployment position exposing the fork.The fork tines were found intact.Visual assessment of sample (2) shows the trigger has been advanced to the proximal end on the handle body indicating a complete deployment.The trigger was moved back to the pre-deployment position exposing the fork.One of the fork tines have been broken off.The suture constructs were also returned showed no abnormalities, the constructs appear to have been cinched properly.Clinical details were provided that the surgeon rotated one of the suture anchor devices after it was seated into the patient¿s bone.Per the device ifu under precautions ¿once seated, do not rotate the suture anchor device in the bone as this may cause device failure.¿ no root cause related to the manufacturing process can be established.Further investigation is not warranted at this time.(b)(4).

• Brand Name: SUTUREFIX UL ANR XL W/1 #2 ULTRABRIAD 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5370159
• MDR Text Key: 36425175
• Report Number: 1219602-2016-00031
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K122059
• 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: 12/21/2015

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 Expiration Date: 01/01/2020
• Device Catalogue Number: 72203841
• Device Lot Number: 50531099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2015
• Initial Date FDA Received: 01/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/13/2016; 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2015
• 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 Age: 37 YR