MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG SA 5.5MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72203706

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during a shoulder surgery the anchor would not deploy off the inserter.An open surgery was performed using an anchor of the same type.No significant delay or patient injuries were reported.

Manufacturer Narrative

One (b)(4) healicoil regenesorb 5.5mm suture anchor device returned.The complaint stated: ¿the anchor would not deploy off the inserter.¿ the healicoil inserter was returned with suture and anchor attached.The anchor had been damaged.There were sections of thread absent.They were not returned.The fracture and damaged distal threads indicate too much torque and pressure was placed upon the anchor upon attempted insertion.The recommended prep instrument for normal bone density is a 5.5mm threaded dilator.No root cause related to the manufacture of this device can be established.No further investigation at this time.

• Brand Name: HEALICOIL RG SA 5.5MM W/2 UB-BL CBRD BL
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, 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 ; 5123585706
• MDR Report Key: 8475258
• MDR Text Key: 140740978
• Report Number: 1219602-2019-00374
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885554031416
• UDI-Public: 00885554031416
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151105
• 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,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2021
• Device Catalogue Number: 72203706
• Device Lot Number: 50742914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• 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