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	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).One 2.4 mm drill tipped passing pin was returned for evaluation.Visual assessment of the device confirmed the reported breakage.The passing pin has broken approximately.883 from its drill tipped end.The tip is damaged in a circular manner at the break area.The corresponding shaft is bent and is missing a segment of material at the location of the break.The shaft of the device is also damaged in a circular manner at several locations along its length.The condition of the device indicates it was subjected to excessive forces during use.Per the device instructions for use, under precautions: ¿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 manufacturing process can be established.
Event or Problem Description
It was reported that, during an acl reconstruction procedure, the drill tip guide wire broke.The broken piece was removed from the body with a grasper.The surgery had been finished with the same device but was extended for 5 min more as consequence of the alleged malfunction.The patient, who had a hard bone quality, did not suffer any adverse event.

• 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: 8531974
• Report Number: 1219602-2019-00437
• Device Sequence Number: 16221288
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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: 014396
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1