MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE WIRE 1.2MM X18 BX OF 5 STER.; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	72201201
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a hip arthroscopy when wire was passed into patient, the tip broke.The broken piece was later retrieved from patient.There was no significant delay or patient injuries reported but it is unknown if a backup was available to complete the procedure.
Additional Manufacturer Narrative
One single 1.2mm x 18¿ 72201201 guide wire returned.These are sold as a box of 5 sterile wires.These are not intended to be sold individually.The complaint stated: ¿when wire was passed into patient the tip broke.¿ the wire was snapped between the 35-40mm incremental markings.The condition indicates the wire was snapped from excess torque or leverage being applied.These wires are intended to flex but not be bent.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity include: 1.Getting entangled up with other instruments or devices.2.Use of other that recommended smith and nephew drill.3.The primary cutting edges of the drill are not sharp or have dings and burrs.4.Stressed product from over torque or loss of axial alignment.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.¿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.
Event or Problem Description
It was reported that during a hip arthroscopy when wire was passed into patient the tip broke.The broken piece was later retrieved from patient.There was no significant delay or patient injuries reported and it is unknown how the procedure was completed since reporter stated that a backup device was not needed and later said that it is unknown if there was one available or not.

• Brand Name: GUIDE WIRE 1.2MM X18 BX OF 5 STER.
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8480655
• Report Number: 1219602-2019-00389
• Device Sequence Number: 13893483
• Product Code: LXH
• UDI-Device Identifier: 03596010587671
• UDI-Public: 03596010587671
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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 Catalogue Number: 72201201
• Device Lot Number: 2018823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1