MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE WR 1.2MM X 12" BOX OF 5 STERILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	7211138
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when screw fixation to femoral, the wire broke inside the patient.The broken piece was removed.No patient injury was reported, but the procedure was extended 2 hours.
Additional Manufacturer Narrative
One single (b)(4) 1.2mm x 18¿guide wire returned.These are sold as a box of five and not intended for individual sale.The complaint stated: ¿it was reported that when screw fixation to femoral, the wire broke in patient.A broken piece was removed.¿ this is a surgical accessory instrument used to assist with arthroscopic procedures.These wires are intended to flex but not bend.The returned wire was snapped due to excess stress.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 this device was confirmed.

• Brand Name: GUIDE WR 1.2MM X 12" BOX OF 5 STERILE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8033539
• Report Number: 1219602-2018-01493
• Device Sequence Number: 1434959
• Product Code: LXH
• UDI-Device Identifier: 03596010559050
• UDI-Public: 03596010559050
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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: 02/29/2020
• Device Catalogue Number: 7211138
• Device Lot Number: 50543907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR