MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203983
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use instruments inside the patient in shoulder arthroscopy, the inserter of the healicoil sheared off at the weld upon insertion.All the broken pieces were removed with a grasper.The procedure was completed with the same device.No delay was reported, and no other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H10: h2: additional information: h6: health effect - impact code.H3, h6: the reported device was received for evaluation.An analysis of the customer provided image showed a broken tip of inserter.A visual inspection revealed the device was not returned with original packaging.The anchor and suture are missing.The tip of the inserter is broken at the weld and is separated from main shaft of device.Further review of twist off found galling on both faces.No other physical damage is visible to the device.A functional evaluation of the returned device was not applicable.A complaint history review concluded this was an isolated event.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.Based on the information available, 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 procedure found that each component should be visually inspected for all non-conforming attributes defined in the procedure.It was determined the device did not contribute to the reported event.Factors, which could have contributed to the complaint event, include an application 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.Per case details, all the broken pieces were retrieved from the patient.The procedure was completed using the same device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.No containment or corrective actions are recommended at this time.

• Brand Name: HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL
• 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: 12858610
• Report Number: 1219602-2021-02556
• Device Sequence Number: 4245397
• Product Code: MBI
• UDI-Device Identifier: 00885554032109
• UDI-Public: 00885554032109
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

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 Model Number: 72203983
• Device Catalogue Number: 72203983
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 03/01/2023
• 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