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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a rotator cuff repair surgery, the healicoil anchor disintegrated when being inserted/screwed into the patient's shoulder following awl hole prep.All pieces were removed with arthroscopic graspers.The procedure was successfully completed with non-significant delay using a competitor device.No further complications were reported.
Additional Manufacturer Narrative
The reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual evaluation of the device showed it wasn't returned in the original packaging.The inserter was not returned.The sutures and anchor were returned.The sutures are still threaded thru the anchor.The anchor is missing multiple ribs and the remaining ribs are deformed.There is bio debris on the sutures and anchor.Based on the condition of the product material, additional material testing is not required.A review of the customer provided image found the break body anchor attached to the suture inside the transparent bag.The device has blood clots particles and seems bent.The complaint was confirmed and the root cause was associated with unintended use of the device.Factor that may have contributed to the reported event include not maintaining inserter alignment throughout insertion to ensure implant integrity.Our clinical investigation concluded: no patient injuries or adverse consequences were reported.Since no patient injuries are being reported and without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.No further medical assessment is warranted at this time.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A review of the anchor material drawing/specifications found that certifications and testing data are required for raw material.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.

• Brand Name: HEALICOIL SA PK 5.5MM W/3 UB-BL CBBL LT
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, 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: 15717401
• Report Number: 1219602-2022-01662
• Device Sequence Number: 20497339
• Product Code: MBI
• UDI-Device Identifier: 00885554026313
• UDI-Public: 00885554026313
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2026
• Device Model Number: 72203380
• Device Catalogue Number: 72203380
• Device Lot Number: 2073024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown