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

Catalog Number	72202797
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guard wire broke inside the patient and could not be removed.A backup device was available to complete the procedure.No delays were reported.
Additional Manufacturer Narrative
One component from a (b)(4) 1.2 rap-bac b kit returned.As sold the 1.2 rap-pac b, latex free kit contains 1 each of the following: 2.4 mm x 12" drill tip guidewire.2.4 mm x 15" drill tip passing pin.1.2 mm x 12" guidewire (5 per package).Cannulated bone tunnel plug, latex free.Trukor gauge.The component returned was only the (b)(4) 1.2mm x 12¿ guidewire.No others.The complaint stated: ¿it was reported that the guard wire broke inside the patient and could not be removed.¿ approximately 1¿ was absent.These wires are intended to flex but not be bent.The condition indicates the wire was snapped from excess force, torque or leverage being applied.No root cause related to the manufacture of this device was confirmed.Has been corrected.
Event or Problem Description
It was reported that during an acl surgery, the guard wire broke inside the patient and could not be removed.A backup device was available to complete the procedure.No delays were reported.

• 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: 8141195
• Report Number: 1219602-2018-01683
• Device Sequence Number: 16616367
• Product Code: NBH
• UDI-Device Identifier: 00885556541289
• UDI-Public: 00885556541289
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 09/13/2023
• Device Catalogue Number: 72202797
• Device Lot Number: 2019873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1