MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203705
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the anchor lacks of one fragment.The implant got broken in the proximal part while it was being inserted, however, the other part of the implant worked correctly and the procedure was completed successfully.The broken piece was removed and patient injuries were no reported.
Additional Manufacturer Narrative
One 72203705 healicoil regenesorb suture anchor was returned.The complaint stated: ¿the implant got broken in the proximal part while it was being inserted¿.Based upon the condition of the anchor, over torque and resistance was a factor.If more torque is required to insert the anchor, stop and ensure that the hole size and depth are correct for the bone conditions encountered.It is the responsibility of the surgeon to determine the patient¿s bone condition, appropriately prepare the insertion site, and determine the suitability of the implant for the procedure.Root cause associated with the manufacture of this device was not confirmed.

• Brand Name: HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8423093
• Report Number: 1219602-2019-00308
• Device Sequence Number: 16701161
• Product Code: MBI
• UDI-Device Identifier: 00885554031706
• UDI-Public: 00885554031706
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K123393
• 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): 03/27/2019

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: 07/27/2021
• Device Catalogue Number: 72203705
• Device Lot Number: 50749362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1