MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72203697
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Rupture (2208); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy procedure, when the 4.75mm healicoil regenesorb suture anchor was inserted into the bone hole, the suture and tape came off the anchor.The anchor could not be removed from the body.The procedure was successfully completed placing a back-up device into an additional drilled bone hole.There was a non-significant surgical delay of 10min, and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product information was provided, thus a manufacturing record review could not be performed.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.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.This case reports, the suture and tape came off the anchor after insertion in the bone and reportedly, ¿the anchor could not be removed from the body.¿ no clinically relevant supporting documentation was provided for review.Based on the limited information provided the root cause of the breakage could not be determined.It is unclear if the ifu [10601068 rev j] were adhered to; however, use of excessive force during insertion can cause failure of the suture anchor or insertion device.Bone quality must be adequate to allow proper placement of the suture anchor.If more torque is required to insert the anchor, stop, and ensure that the hole size and depth are correct for the bone conditions encountered.If a portion of the anchor remains retained in the patient, it is made of a bio-composite material which is intended for implantation to allow for bone ingrowth.Since the anchor was retained, it is unknown if the anchor will migrate and there is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted at this time.There was no relationship found between the device and the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL
• 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: 15136065
• Report Number: 1219602-2022-01077
• Device Sequence Number: 14769320
• Product Code: MAI
• UDI-Device Identifier: 00885554031393
• UDI-Public: 885554031393
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/11/2022

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 Catalogue Number: 72203697
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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