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

Model Number 72205137

Device Problems Break (1069); Firing Problem (4011)

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

Event Date 09/28/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during an arthroscopy procedure using 2 healicoil suture anchor, the inserter could not be separated from the anchor.The procedure was successfully completed with non-significant delay using a back-up device in the originally drilled bone hole.No patient complications were reported.According to results of investigation it was found that the anchor is broken on the inserter.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual inspection found the device had original packaging that showed the lot number.The proximal body is intact on the device but is broken and looks as if anchor was removed and not aligned when put back on.The anchor looks to be jammed back on the inserter.One of the guides is flared out on inserter shaft.The distal tip and anchor plug is detached from device and missing.No other physical damage is visible to the device.The device has debris.Functional evaluation found the proximal body was able to deploy for the device, but there was resistance due to being jammed shaft.Mechanical portion of the device does work.Device passed all functional tests.A review of the customer provided image found a device and labelling within plastic packaging.The labelling and device were obscured by the packaging, therefore, the condition of the device could not be determined in the image.It was determined the device did not contribute to the firing problem.The firing problem was not confirmed.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.It was determined the device contributed to the broken anchor.The complaint was confirmed for the broken anchor, and the root cause was associated with unintended use of the device.Factors, which could have contributed to the complaint event, include an application of unintended or inappropriate or excessive force to the device.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.Our clinical investigation concluded: this case reports, while using the suture anchor during an arthroscopy procedure, ¿the inserter could not be separated from the anchor.¿ the procedure was completed with a backup device in the originally drilled bone hole.Per case correspondence, no broken pieces of the inserter fell inside the patient.No patient complications were reported, and no harm has been alleged.Therefore, no further clinical/medical assessment is warranted.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the material found there are requirements for conformance and a certificate of material analysis is required.Based on the condition of the product material found during visual inspection, additional material testing is not required.No containment or corrective actions are recommended at this time.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14325653
• MDR Text Key: 291199848
• Report Number: 1219602-2022-00651
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885556767337
• UDI-Public: 00885556767337
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K193558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2024
• Device Model Number: 72205137
• Device Catalogue Number: 72205137
• Device Lot Number: 50932396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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
• Patient Outcome(s): Other