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

Model Number 72203380

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/01/2020

Event Type  Injury  

Event Description

It was reported that, during a procedure, as the healicoil was being inserted it broke.There was a backup device available.No significant delay or further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that, during a procedure, as the healicoil was being inserted it broke.Pieces were removed using tweezers.There was a backup device available.No significant delay or further complications were reported.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated issue.A review of the provided customer image revealed the anchor was broken.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of the print specification found that each component should be visually inspected for all non-conforming attributes defined in the procedure and according to the acceptance criteria on the part drawing or data sheets.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.

• 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 blvd.; mansfield MA 02048
• MDR Report Key: 10733974
• MDR Text Key: 213012451
• Report Number: 1219602-2020-01658
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554026313
• UDI-Public: 00885554026313
• Combination Product (y/n): N
• PMA/PMN Number: K113294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2020
• Device Model Number: 72203380
• Device Catalogue Number: 72203380
• Device Lot Number: 50578471
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 10/26/2020; 05/12/2021
• Supplement Dates FDA Received: 10/27/2020; 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention