MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RAP-PAC B 1.2; ACCESSORIES,ARTHROSCOPIC

Model Number 72202797

Device Problems Break (1069); Sticking (1597)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/22/2018

Event Type  malfunction  

Event Description

It was reported that it was used a 1.2mm guide wire to guide the biorci screw and once screw was implanted he tried to remove guidewire that appeared to be stuck.Guidewire broke leaving part of wire in the bone.It was took an x-ray post operation and it was saw that approx.5mm was in the bone.It was left in the patient as is.

Manufacturer Narrative

One 1.2mm nitinol guidewire from a rap-pak b was returned for evaluation.Visual assessment of the guidewire confirmed the reported breakage.Approximately 3/8¿ of the distal end of the guidewire has been broken off.The broken piece was not returned.The break area is bent and shows signs of elastic deformation.The devices condition indicates it was subjected to excessive force during use.As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in failure.No root cause related to the manufacture of the device can be established.

• Brand Name: RAP-PAC B 1.2
• 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: 7303180
• MDR Text Key: 101346577
• Report Number: 1219602-2018-00272
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556541289
• UDI-Public: (01)00885556541289(17)220505(10)50662768
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2022
• Device Model Number: 72202797
• Device Catalogue Number: 72202797
• Device Lot Number: 50662768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2017
• 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: 21 YR