MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72203708
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that during the procedure, the healicoil broke when inserted into the bone hole.Bone hole was made using a 3.8 straight owl.All the pieces were successfully removed from patient.The procedure was successfully completed with a 10 minutes delay using a back-up device.No patient injury or other complications were reported.
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.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.A review of the material found there are requirements for conformance and a certificate of material analysis is required.A visual inspection reveals the device was returned outside of original packaging.The anchor was attached to the device and was fractured along one side.The sliding ring had not been actuated to release the suture.No physical damage visible to the shaft or the handle of the handheld device.Based on the condition of the product material found during visual inspection it was determined that additional material testing is not required.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.No containment or corrective actions are recommended at this time.

• Brand Name: HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12235277
• Report Number: 1219602-2021-01622
• Device Sequence Number: 3962491
• Product Code: MAI
• UDI-Device Identifier: 00885554031423
• UDI-Public: 00885554031423
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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: 02/03/2024
• Device Catalogue Number: 72203708
• Device Lot Number: 50920065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1