MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL PK 4.5MM W/ ULTRA TAPE CBRD; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203982
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a mini open mpfl repair, the healicoil anchor broke when screwing in.The pieces were removed with a grasper.The patient's bone quality was normal.The procedure was completed using a s+n back up device into the original bone hole.There was a non-significant delay and no further complications were reported.
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 analysis of the customer provided image showed a chart-stik label.A complaint history review found 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 there was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Factors, which could have contributed to the complaint event, include applications of unintended inappropriate or excessive force to the device.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.Smith and nephew has not received the device/relevant clinical supporting documentation to perform a thorough medical investigation.Therefore, a thorough medical investigation cannot be rendered nor can the clinical root cause of the reported failure be determined.Based on the information provided, the patient¿s bone quality was normal, and all the broken pieces of the healicoil anchor were removed from inside of the patient with a grasper.It was reported, the procedure was completed using a s+n back up device in the original bone hole with a non-significant delay.Since no further complications were reported, no further clinical/medical assessment is warranted at this time.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 PK 4.5MM W/ ULTRA TAPE CBRD
• 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: 13112938
• Report Number: 1219602-2021-02799
• Device Sequence Number: 17067048
• Product Code: MBI
• UDI-Device Identifier: 00885554032130
• UDI-Public: 00885554032130
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K113294
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: 07/22/2024
• Device Model Number: 72203982
• Device Catalogue Number: 72203982
• Device Lot Number: 2037200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2019
• 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