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

Model Number	72202797
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7303180
• Report Number: 1219602-2018-00272
• Device Sequence Number: 1301294
• Product Code: NBH
• UDI-Device Identifier: 00885556541289
• UDI-Public: (01)00885556541289(17)220505(10)50662768
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR