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

Model Number 72203379

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2019

Event Type  malfunction  

Event Description

It was reported that during a glute repair while the surgeon was trying to screw the device it got broken.No patient injuries or delay reported.Back-up device was available to complete the surgery.

Manufacturer Narrative

One healicoil pk 5.5mm-2 ub blue-cobraid device used for treatment, were not returned for evaluation.Due to product unavailability, the complaint could not be visually evaluated.Definitive conclusions, accurate investigation and evaluation were limited without evaluation of physical product.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will certainly be revisited.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: 1.Damaged or use of other than recommended prep instrument size or types.2.Pressure or excess torque applied.3.Inadequate bone quality resulting in anchor pullout or loss of fixation.4.Unexpected bone condition/density.5.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 used on normal bone condition is a 3.8mm tapered awl.Communication relayed use of a 5.5mm awl.Final product met specifications upon release to distribution.Complaint history review found no other reports for this lot.Product met specifications upon release to distribution.

Manufacturer Narrative

H10: h3, h6: one 72203379 healicoil pk 5.5mm-2 ub blue-cobraid device used for treatment and was returned for evaluation.There was heavy surgical matter attached to the anchor body as well as the inserter.Per instructions for use, this product is intended for shoulder, knee, foot and ankle applications.The complaint indicated use for a ¿glute¿ procedure which would be aligned with a hip procedure.Longer shaft devices are available.Cobraid sutures were returned attached to the anchor.Suture strands were not in original location, all four were on one side of the anchor indicating excessive twisting or removal and replacement of anchor onto the inserter.There was no apparent damage to the inserter shaft or forks.The anchor was fractured and had distal damaged from twisting and excess torque.The symptoms were consistent with loss of axial alignment and, or inadequate prep diameter.Per instructions for use ¿breakage of the suture anchor can occur if insertion sites are not properly prepared prior to implantation.Proper hole depth is achieved when the laser depth mark or circular groove on the distal end of the awl contacts the bone surface.Hold the awl in place and use a mallet to tap the proximal end to prepare the insertion site.Establish and maintain axial alignment of the suture anchor to the prepared insertion site and place the tip of the anchor into the prepared hole.Excessive force during insertion can cause failure of the suture anchor or insertion device.¿ a 3.8mm straight awl is the recommended prep instrument for normal bone condition.Complaint history review for three years past indicated similar allegations for the product code reported.Dhr/batch/lot review was unattainable without a valid lot number provided.No root cause related to the manufacturing of this device was confirmed.No further investigation is warranted at this time.

• Brand Name: HEALICOIL SA PK 5.5MM W/2 UB-BL CBRD BL
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8952894
• MDR Text Key: 156306527
• Report Number: 1219602-2019-01057
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554026306
• UDI-Public: 00885554026306
• Combination Product (y/n): N
• PMA/PMN Number: K113294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203379
• Device Catalogue Number: 72203379
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1