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	11/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery when inserting the anchor into the bone, the anchor was broke.No significant delay was reported, a backup device was available to complete the procedure with no patient injuries.
Additional Manufacturer Narrative
One 72203706 healicoil regenesorb 5.5mm suture anchor device 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.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.Breakage of the suture anchors can occur if insertion sites are not prepared with appropriate instrumentation prior to implantation.Use of excessive force during insertion can cause failure of the suture anchor or insertion device¿.Recommended prep instrument for the 5.5mm anchor is a 5.5mm threaded dilator.Communication relayed use of a 4.75mm tap.Final product met predetermined specifications upon release to distribution.
Additional Manufacturer Narrative
One 72203706 healicoil regenesorb 5.5mm suture anchor device 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.Recommended prep instrument for the 5.5mm anchor is a 5.5mm threaded dilator.Communication relayed use of a 4.75mm tap.Final product met predetermined specifications upon release to distribution.
Event or Problem Description
It was reported that during procedure, when inserting the anchor into the bone, the anchor was broke.All the pieces were removed.A backup device was available to complete the procedure with no significant delay and no patient injuries.

• 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: 8155232
• Report Number: 1219602-2018-01736
• Device Sequence Number: 268439
• Product Code: MAI
• UDI-Device Identifier: 00885554031416
• UDI-Public: 00885554031416
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2019

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: 04/24/2021
• Device Catalogue Number: 72203706
• Device Lot Number: 50729471
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/15/2019; 02/27/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/15/2019; 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1