MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203983
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff procedure, the inserter shaft snapped and fell into the patient.Piece was retrieved from the patient.A backup device was available to complete the procedure with no delay or patient injuries.
Additional Manufacturer Narrative
One 72203983 healicoil pk 5.5mm product returned.The complaint stated: ¿the inserter shaft snapped and fell into the patient.¿ there was no ultrabraid, ultratape or anchor returned.The only return was the inserter, which was separated into two pieces.The weld was broken.The shaft diameter has been slightly flared where the tip joins.This condition is caused by torque.Breakage of the suture anchors can occur if insertion sites are not prepared with appropriate instrumentation prior to implantation, and also 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.As an additional safe measure an engineering study has been generated to further investigate this failure mode.Complaints for this mode are being monitored.At this time, no root cause associated with the manufacture of this device was confirmed.

• Brand Name: HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8103513
• Report Number: 1219602-2018-01628
• Device Sequence Number: 13959909
• Product Code: MBI
• UDI-Device Identifier: 00885554032109
• UDI-Public: 00885554032109
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K113294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 07/19/2023
• Device Catalogue Number: 72203983
• Device Lot Number: 2017767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1