MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG SA 4.75MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72203704
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a hamstring rupture procedure, two healicoil anchors were fractured.The bone holes were made using a straight awl (a dilator was not used).It is unknown how the procedure was completed or if there was a surgical delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual evaluation of the device showed that it was not returned in the original packaging.Two of the sutures are still wrapped over the fork/inserter of the device and threaded through the cannula/handle.The anchor is on the inserter but missing some ribs.There is bio debris between ribs, on the sutures, and on the inserter.A functional evaluation of the device showed that the sliding ring still functioned as intended.Based on the condition of the product material found during visual inspection, additional material testing is not required.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A review of the process summary, each component should be visually inspected for all non-conforming attributes.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.This case reports, the fracture of two healicoil anchors in a hamstring rupture procedure where a straight awl instrument was reportedly used create a ¿bone holes¿.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 contributed to the event.Information regarding how the procedure was completed, if back-up devices was used, or whether a procedural delay occurred are also unknown.The patient impact: per case communication, ¿no damage was caused.¿ additionally, no patient harm or injury has been alleged.Therefore, no further clinical/medical assessment is warranted.The complaint was confirmed and the root cause was associated with unintended use of the device.Factor that may have contributed to the reported event include use of excessive force during insertion can cause failure of the anchor or insertion device.No containment or corrective actions are recommended at this time.Correction in a1 (should be read in blank).

• Brand Name: HEALICOIL RG SA 4.75MM 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
• 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: 15535506
• Report Number: 1219602-2022-01466
• Device Sequence Number: 15411836
• Product Code: MAI
• UDI-Device Identifier: 00885554030310
• UDI-Public: 00885554030310
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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: 01/14/2025
• Device Model Number: 72203704
• Device Catalogue Number: 72203704
• Device Lot Number: 2085262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2022
• 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: Other
• Patient Sex: Unknown