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

Catalog Number	72205136
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a rotator cuff repair, the healicoil's proximal anchor broke when it was inserted into the bone hole.All pieces were removed from the patient.The procedure was completed with a non-significant surgical delay using a back-up device in the originally drilled bone hole.No further complications were reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was not returned with original packaging.The lower part of proximal body, distal tip and anchor plug is still intact and on the device.The upper part of the proximal body is broken off.No other physical damage is visible to the device.A functional evaluation of the returned device found that mechanical portion of the device does work.Device passed all functional tests.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 polymer found that the storage requirements, material specifications, and material tests were appropriately documented.Based on the condition of the product material found during visual inspection it was determined the device damage was caused by the application of improper/excessive force.Additional material testing is not required.It was determined the device contributed to the reported event.Per subsequent email, no further relevant clinical information will be provided for inclusion in this medical investigation.Therefore, a thorough medical investigation cannot be rendered nor could the clinical root cause of the reported breakage be determined.Based on the information provided, all pieces of the broken healicoil proximal anchor were removed from inside of the patient.According to the report, the surgery was completed by the surgeon with a non-significant surgical delay using a back-up device.Since there were no patient complications reported, no further clinical/medical assessment is warranted at this time.The complaint was confirmed, 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.No containment or corrective actions are recommended at this time.

• Brand Name: HEALICOIL KNOTLESS RG ST
• Common Device Name: 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: 13847357
• Report Number: 1219602-2022-00408
• Device Sequence Number: 4730390
• Product Code: MAI
• UDI-Device Identifier: 00885556767320
• UDI-Public: 885556767320
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: 07/31/2023
• Device Catalogue Number: 72205136
• Device Lot Number: 50887737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 03/22/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• 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
• Patient Age: 60 YR
• Patient Sex: Male