MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203983
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use in a rotator cuff repair, the bottom threads of the healicoil anchor broke off when screwing into the bone.Pieces were removed by suction and nothing was left behind in the patient.The insertion site was cleared from all debris prior the insertion of the anchor.The procedure was completed with non-significant surgical delay and was finished with a smith and nephew back up device in the same bone hole.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.An analysis of the customer provided images showed picture of the device box and a broken anchor on a inserter.A visual inspection revealed the device was returned with original packaging.The anchor is still on the inserter and the anchor¿s lower threads are broken off.There is only four upper threads left and the sutures have been cut from the lower portion of the device and are missing, the remainder of the sutures are still wrapped around the handle 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.It was determined the device contributed to the reported event.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.A complaint history review found no 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 specifications 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 it was determined the device damage was caused by the application of improper/excessive force.Additional material testing is not required.No containment or corrective actions are recommended at this time.One undated photo of the device was provided for review and confirms the reported breakage.Per case details, the broken anchor was retrieved from the patient.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.

• Brand Name: HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL
• 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: 13806418
• Report Number: 1219602-2022-00389
• Device Sequence Number: 19924909
• Product Code: MBI
• UDI-Device Identifier: 00885554032109
• UDI-Public: 00885554032109
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K113294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: 02/21/2026
• Device Model Number: 72203983
• Device Catalogue Number: 72203983
• Device Lot Number: 2067965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2021
• 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 Sex: Unknown