MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL SA PK 4.5MM W/2 UB-BL, CBRD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72203378

Device Problem Break (1069)

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

Event Date 12/11/2018

Event Type  malfunction  

Event Description

It was reported that the anchor broke when it was screwed after awling.A backup device was available to complete the procedure with no significant delay or patient injuries.

Manufacturer Narrative

Additional information.Correction in: first name: (b)(4); last name: (b)(6); facility name: (b)(4).Health professional: no unchecked.

Event Description

It was reported that the anchor broke when it was screwed in.The broken pieces were removed from patient.A backup device was available to complete the procedure with no significant delay or patient injuries.

Manufacturer Narrative

One 4.5mm healicoil pk sa assembly was returned for evaluation.Visual assessment of the device confirmed the reported breakage.The distal threads of the anchor have broken off and were not returned.The material surface area of the anchor where the threads have broken is heavily burnished.The condition of the anchor indicates axial alignment was not maintained during insertion causing the anchor to come in contact with the cortical bone layer resulting in the threads breakage.No root cause related to the manufacturing process can be established.

• Brand Name: HEALICOIL SA PK 4.5MM 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8198190
• MDR Text Key: 131478059
• Report Number: 1219602-2018-01798
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010657862
• UDI-Public: 03596010657862
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K113294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2023
• Device Catalogue Number: 72203378
• Device Lot Number: 50737589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 01/17/2019; 02/04/2019
• Supplement Dates FDA Received: 01/17/2019; 02/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1