MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG SA 5.5MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72203706
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that the thread has remained blocked on the anchor when the surgeon wanted to remove the device.The anchor has been changed.No patient injury was reported.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
Event or Problem Description
It was reported that during procedure, a thread has remained blocked on the anchor when the surgeon wanted to remove the device.The anchor has been changed.No patient injury was reported.It is unknown if there was a delay, there was no confirmation on loss of tissue fixation or any additional bone hole made.Attempts were made to retrieve further information but no response was received from the complainant.

• Brand Name: HEALICOIL RG SA 5.5MM W/2 UB-BL CBRD BL
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8155876
• Report Number: 1219602-2018-01737
• Device Sequence Number: 19234000
• Product Code: MAI
• UDI-Device Identifier: 00885554031416
• UDI-Public: 00885554031416
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2020
• Device Catalogue Number: 72203706
• Device Lot Number: 50698533
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1