MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL SA PK 5.5MM W/3 UB-BL, CBBL,LT

Model Number 72203380

Device Problems Break (1069); Crack (1135); Loose or Intermittent Connection (1371)

Patient Problem Discomfort (2330)

Event Date 08/13/2014

Event Type  malfunction  

Event Description

A rotator cuff repair procedure was completed using a healicoil sa pk 5.5mm w/3 ub-bl, cbbl, lt.The anchor site was prepped with a 5.5-6.5 threaded awl/dilator.Approximately 6-7 months post procedure the patient returned to the physician complaining of discomfort.A second scope was performed and the physician found that the anchor had pulled loose from the bone.The anchor appeared to be cracked longitudinally.The sutures and the broken anchor were removed.The same site was prepped again and another healicoil sa pk 5.5mm w/3 ub-bl, cbbl, lt was inserted.There were no reports of patient injuries.

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.(b)(4).

Manufacturer Narrative

Additional information received provided additional patient information.Patient's age and birthdate added.(b)(4).

• Brand Name: HEALICOIL SA PK 5.5MM W/3 UB-BL, CBBL,LT
• Type of Device: HEALICOIL
• 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: brenda driscoll ; 150 minuteman road; andover, MA 01810 ; 9787491462
• MDR Report Key: 4209265
• MDR Text Key: 5153180
• Report Number: 1219602-2014-00300
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2014

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: 09/30/2018
• Device Model Number: 72203380
• Device Catalogue Number: 72203380
• Device Lot Number: 50474600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2014
• Initial Date FDA Received: 10/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2013
• 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
• Patient Age: 69 YR
• Patient Weight: 73