MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL KNOTLESS PK NST; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72205137

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

It was reported that during a double row cuff repair surgery, once the first part of the healicoil was impacted and the suture (the black thread) was blocked, the threaded part was started to be lowered by turning the orange part.As the threaded part touched the bone, pieces of each thread began to pop off.A backup device was available to complete the procedure with no delay or other complications.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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.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 review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found breakage of the suture anchor can occur if insertion sites are not prepared with the appropriate instrumentation prior to implantation.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: HEALICOIL KNOTLESS PK NST
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10916237
• MDR Text Key: 218644595
• Report Number: 1219602-2020-01959
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556767337
• UDI-Public: 00885556767337
• 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
• Report Date: 01/12/2021

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: 07/29/2023
• Device Model Number: 72205137
• Device Catalogue Number: 72205137
• Device Lot Number: 50887381
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/29/2020
• Supplement Dates Manufacturer Received: 12/29/2020
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention