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

Catalog Number	72203984
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the anchor broke.The pieces were removed with a forceps.A back-up device was available to complete the procedure with no significant delay or patient injuries.
Additional Manufacturer Narrative
One (b)(4) healicoil pk 5.5mm product returned.The complaint stated: ¿during the application the inserter broke apart.The tip of the inserter with the anchor attached were removed with a forceps.¿ no suture or anchor was returned.The only return was the inserter, which was separated into two pieces.The weld was broken.The shaft diameter has some dings at the weld joint area.No root cause associated with the manufacture of this device was confirmed.
Additional Manufacturer Narrative
Event description updated.
Event or Problem Description
It was reported that during the application the inserter broke apart.The tip of the inserter with the anchor attached were removed with a forceps.A backup device was available to complete the procedure with no significant delay or patient injuries.

• Brand Name: HEALICOIL PK 5.5MM W/ UB2-BL UTP CBRD
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8149369
• Report Number: 1219602-2018-01704
• Device Sequence Number: 18895212
• Product Code: MBI
• UDI-Device Identifier: 00885554032116
• UDI-Public: 00885554032116
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113294
• 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): 02/14/2019

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: 05/08/2023
• Device Catalogue Number: 72203984
• Device Lot Number: 2013952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 11/29/2018; 02/13/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 12/20/2018; 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR