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

Model Number	72203708
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopy procedure, when the doctor tied the suture knots, after implanting the healicoil anchor; the anchor pulled out of the bone with the coils of the anchor shattered.He cut the anchor out and replaced it with another healicoil anchor; broken pieces were retrieved from patient with a grasper, a new hole was made with the 5.5 healicoil tap.The procedure was successfully completed with non-significant delay using a back-up device.No patient complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H10 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.An evaluation of the customer provided surgical images showed in image one, a partial view of an anchor.It appears that at least one anchor rib is broken.Tissue is obstructing a full view of the anchor.In image two the anchor is laying on a surgical table.Multiple ribs are broken and/or missing on one side of the anchor.Image three is another surgical image of the anchor which shows multiple anchor ribs broken.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the anchor material drawing/specifications found that the material is tested to comply with specifications.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The patient impact beyond the reported is not anticipated as the broken pieces were reportedly removed and the patient¿s current health status per email correspondence is ¿the patient is doing well,¿ and ¿no patient complications reported.No patient injury has been alleged.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.There was a relationship found between the device and the reported event.The complaint of device dislodged or dislocated was confirmed and the root cause was associated with unintended use of the device.Factor that may have contributed to the reported event include an application of unintended excessive force during manipulation of the sutures.The complaint of break was confirmed and the root cause was associated with unintended use of the device.Factor that may have contributed to the reported event include not maintaining inserter alignment throughout insertion to ensure implant integrity.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.
Additional Manufacturer Narrative
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.An evaluation of the customer provided surgical images showed in image one, a partial view of an anchor.It appears that at least one anchor rib is broken.Tissue is obstructing a full view of the anchor.In image two the anchor is laying on a surgical table.Multiple ribs are broken and/or missing on one side of the anchor.Image three is another surgical image of the anchor which shows multiple anchor ribs broken.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the anchor material drawing/specifications found that the material is tested to comply with specifications.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The patient impact beyond the reported is not anticipated as the broken pieces were reportedly removed and the patient¿s current health status per email correspondence is ¿the patient is doing well,¿ and ¿no patient complications reported.No patient injury has been alleged.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.There was a relationship found between the device and the reported event.The complaint of device dislodged or dislocated was confirmed and the root cause was associated with unintended use of the device.Factor that may have contributed to the reported event include an application of unintended excessive force during manipulation of the sutures.The complaint of break was confirmed and the root cause was associated with unintended use of the device.Factor that may have contributed to the reported event include not maintaining inserter alignment throughout insertion to ensure implant integrity.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 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
• 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: 12815220
• Report Number: 1219602-2021-02507
• Device Sequence Number: 11936835
• Product Code: MAI
• UDI-Device Identifier: 00885554031423
• UDI-Public: 00885554031423
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K123393
• 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,Followup
• Report Date (Section B): 01/02/2023

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: 05/09/2024
• Device Model Number: 72203708
• Device Catalogue Number: 72203708
• Device Lot Number: 2070600
• 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: 10/26/2021
• Supplement Date Received by Manufacturer: 01/29/2023; 12/29/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 01/02/2023; 01/02/2023
• Date Device Manufactured: 05/09/2021
• 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: Male