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

Model Number	72203981
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a shoulder arthroscopy, the "4.5mm helicoil peek anchor" torn off after implantation.In consequence, the anchor was removed from the patient.The procedure was successfully completed using a multifix anchor as back-up device into an additional bone hole.There was a surgical delay greater than 30 minutes (one hour) and no other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6, h10: the reported 4.5 mm healicoil sa pk, used in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the anchor broke during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force placed on the anchor during insertion.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Per e-mail communication, the healicoil anchor which was torn off after implantation was removed from the patient.It was further reported that the procedure was successfully completed using a multifix anchor as back-up device into an additional bone hole.No patient injuries or other complications were reported, and the device will not be returned for evaluation.Therefore, since no patient harm is being alleged, no further assessment is warranted at this time.

• Brand Name: HEALICOIL PK 4.5MM W/ ULTRA TAPE BLUE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10273911
• Report Number: 1219602-2020-01034
• Device Sequence Number: 3399071
• Product Code: MBI
• UDI-Device Identifier: 00885554032123
• UDI-Public: 00885554032123
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: K113294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2025
• Device Model Number: 72203981
• Device Catalogue Number: 72203981
• Device Lot Number: 2048451
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention