MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL SA PK 5.5MM W/3 UB-BL, CBBL,LT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72203380

Device Problem Component Falling (1105)

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

Event Date 05/28/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Only one axial rib from the healicoil anchor was returned for evaluation confirming the reported breakage.The failure mode of connection between threads and axial rib breakage the complaint occurrence rate is 0.034%, while the predicted rate is 0.05%.This data supports the fact that the product is within a level of tolerable risk.A review of the device history record was performed which confirmed no inconsistencies.There were no internal processing issues, which could have contributed to the nature of this complaint.A complaint history review identified no additional complaints for this lot on file.As a result no root cause related to the manufacture of the device can be established.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

During the tensioning, after the insertion of the anchor, it was noticed that a piece of the anchor fell off from the site.All of the pieces were removed from the patient's joint with a grasper.As the most part of the anchor remained in the site, the surgeon estimated that it is strong enough to fix the tendon.The site was prepared with 3.8mm tapered awl.The patient's bone is noted to be normal.No patient injury or other complications were reported.

• Brand Name: HEALICOIL SA PK 5.5MM W/3 UB-BL, CBBL,LT
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5975953
• MDR Text Key: 55905092
• Report Number: 1219602-2016-01071
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K110545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 72203380
• Device Lot Number: 50467029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2014
• Date Manufacturer Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1