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

Catalog Number 72203380

Device Problem Misassembled (1398)

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

Event Date 06/11/2015

Event Type  malfunction  

Event Description

During an unknown procedure using a healicoil sa pk 5.5mm w/3 ub-bl, cbbl, it was reported that the implant was incorrectly assembled.The anchor with incorrect color sutures was discovered after insertion of the anchor.There were 2 cobraid black sutures and 1 cobraid blue with no blue suture.The device will not be returning as it was successfully implanted in the patient.

Manufacturer Narrative

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

Manufacturer Narrative

Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was performed which confirmed no inconsistencies.No further investigation is warranted at this time.

• Brand Name: HEALICOIL SA PK 5.5MM W/3 UB-BL, CBBL,LT
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4905584
• MDR Text Key: 6536564
• Report Number: 1219602-2015-00281
• 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,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2020
• Device Catalogue Number: 72203380
• Device Lot Number: 50543624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2015
• Date Device Manufactured: 03/30/2015
• 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