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

Model Number 72205137

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 10/13/2020

Event Type  Injury  

Event Description

It was reported that during a left shoulder rotator cuff repair, open incision and double row suture bridge repair, the first anchor of the helicoil device was deployed without issues, a good bone quality was noticed during the insertion.A pilot hole was created in order to deployed the second anchor but during the insertion, the anchor pulled out on testing.All the material was removed and the surgeon noticed in the second deployment that the bone was extremely soft.An additional attempt was made to reposition pilot hole with 3.8 awl and noted a poor and soft quality of the bone.Surgeon discontinued to attempt inserting the anchor and performed a trans-osseous suture technique.A bone cyst formation may have played a role in bone quality.No significant delay or other complications were reported.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 complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found: o pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation o pathological conditions in the soft tissues to be attached that would impair secure fixation by suture o do not attempt to implant this device within cartilage epiphyseal growth plates or non-osseous tissue 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.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, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10786449
• MDR Text Key: 214593461
• Report Number: 1219602-2020-01767
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885556767337
• UDI-Public: 00885556767337
• Combination Product (y/n): N
• PMA/PMN Number: K193558
• 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: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2023
• Device Model Number: 72205137
• Device Catalogue Number: 72205137
• Device Lot Number: 50885194
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR