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	04/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the first implant was placed and it was anchored perfectly, then the implant was started with its respective initiator , but when it was being screwed it got broken.No patient injuries or delay were reported.Back-up device was available to complete the surgery.
Additional Manufacturer Narrative
One 72203706 healicoil pk 5.5mm suture anchor reported on.Due to product unavailability, the complaint could not be visually evaluated.Evaluation results were based upon information relayed.Factors that may affect device performance include: device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity that are unrelated to manufacture include: damaged or use of other than recommended prep instrument size or types.Pressure or excess torque applied.Inadequate bone quality resulting in anchor pullout or loss of fixation.Unexpected bone condition/density.Breakage and damage can occur due to use of sharp instruments to manage or control the suture.
Additional Manufacturer Narrative
One healicoil regenesorb 5.5mm suture anchor product returned.The complaint is listed as ¿when it was screwed it was broken.¿ the observation surrounds the fractured anchor.The other components are undamaged.Instructions for use details proper use of the tensioning mechanism and release of the anchor.There were twisted suture at the distal tip of the inserter.There was a small fragment of fractured regenesorb anchor crossbar caught up in the suture.The condition indicates excess torque and pressure was placed upon the anchor during attempted insertion.Recommended prep instrument for normal bone density is a 5.5mm threaded dilator.Please note: per instructions for use: ¿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.¿ no root cause related to the manufacture of this device was established.

• 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: 8501524
• Report Number: 1219602-2019-00413
• Device Sequence Number: 19108655
• Product Code: MAI
• UDI-Device Identifier: 00885554031416
• UDI-Public: 00885554031416
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 06/11/2019

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: 08/07/2020
• Device Catalogue Number: 72203706
• Device Lot Number: 50678595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/24/2019; 06/11/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/27/2019; 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1