MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL TIP GUIDE WIRE,2.4MM; PASSER

Catalog Number	014396
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire broke off.Broken piece was removed from patient.No patient injury or delay was reported.
Additional Manufacturer Narrative
One 2.4 drill tip guide wire was returned for evaluation.Visual assessment of the guide wire confirmed the reported breakage.The guide wire is bent at the break area.A major area of abrasion is located at the breakage.The condition of the device indicates the drill came in contact with the guide wire when over drilling causing the observed damage.Drilling over a bent guide wire would require the use of excessive force.Per the devices ifu ¿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¿.

• Brand Name: DRILL TIP GUIDE WIRE,2.4MM
• Common Device Name: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8061305
• Report Number: 1219602-2018-01520
• Device Sequence Number: 19364241
• Product Code: HWQ
• UDI-Device Identifier: 03596010374691
• UDI-Public: 03596010374691
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K920621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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 Catalogue Number: 014396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1