MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL SA PK 5.5MM W/3 UB-BL CBBL LT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203380
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during use, two (2) healicoil suture anchor broke when being screwed in, the pieces were removed using a grasper.Surgery was resumed after a non-significant surgical delay, using a back-up device instead.It was necessary to drill a new bone hole.The current state of the patient is normal.No further 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 image showed the anchor inside of the patient.The anchor has broken ribs protruding.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 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.A review of the anchor material drawing/specifications found that certifications and testing data are required for raw material.One undated intraoperative photo was provided for review and confirms the reported breakage.Per case details, the broken pieces were retrieved from the patient.The procedure was completed using a back-up device.No further risk to the patient is anticipated as a result of the additional bone hole.Since no further harm is anticipated no further clinical assessment is warranted at this time.There was a relationship found between the device and the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that may have contributed to the reported event include not maintaining inserter alignment throughout insertion to ensure implant integrity or use of excessive force during insertion.No containment or corrective actions are recommended at this time.

• Brand Name: HEALICOIL SA PK 5.5MM W/3 UB-BL CBBL LT
• 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: 15312526
• Report Number: 1219602-2022-01259
• Device Sequence Number: 15035490
• Product Code: MBI
• UDI-Device Identifier: 00885554026313
• UDI-Public: 00885554026313
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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 Model Number: 72203380
• Device Catalogue Number: 72203380
• Device Lot Number: 2080756
• 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: 08/09/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 10/06/2022
• Date Device Manufactured: 10/18/2021
• 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: Unknown