MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG SA 5.5MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72203706
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
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, the healicoil anchor broke on insertion.All pieces were removed.The procedure was completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.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 visual inspection revealed the device was returned outside of original packaging with the anchor still attached to the device.The anchor has been broken at the distal tip.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.A review of the drawings found the device is visually inspected with unaided eye, parts must not have dust, lubricants, other foreign matter, contaminates and embedded particulate.The material composition must comply with specifications, which is validated through testing.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 review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.Internal complaint reference: (b)(4).

• Brand Name: HEALICOIL RG SA 5.5MM W/2 UB-BL CBRD BL
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11536946
• Report Number: 1219602-2021-00577
• Device Sequence Number: 3827861
• Product Code: MAI
• UDI-Device Identifier: 00885554031416
• UDI-Public: 00885554031416
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 08/22/2023
• Device Model Number: 72203706
• Device Catalogue Number: 72203706
• Device Lot Number: 2058968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 03/21/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention