MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL SA PK 4.5MM W/2 UB-BL, CBRD BL; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72203378

Device Problem Device Slipped (1584)

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

Event Date 07/20/2017

Event Type  malfunction  

Event Description

It was reported that while the surgeon was managing the sutures/tying knots, the anchor came back out of the bone and had to be cut out.No further patient injuries were reported.

Manufacturer Narrative

Due to no product was returned, the complaint could not be confirmed.Evaluation and investigation were not possible.No definitive conclusions were made without pertinent manufacturing information or a device to evaluate.If relevant information becomes available to assist with traceability, the complaint will be revisited.Evaluation codes updated.

• Brand Name: HEALICOIL SA PK 4.5MM W/2 UB-BL, CBRD BL
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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
• MDR Report Key: 6757057
• MDR Text Key: 81586924
• Report Number: 1219602-2017-00831
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

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: 03/16/2022
• Device Catalogue Number: 72203378
• Device Lot Number: 50653224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 08/01/2017
• Supplement Dates Manufacturer Received: 09/07/2017
• Supplement Dates FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• 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: 73 YR