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

Catalog Number 014396

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2019

Event Type  malfunction  

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 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
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8531974
• MDR Text Key: 142615100
• Report Number: 1219602-2019-00437
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010374691
• UDI-Public: 03596010374691
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K920621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1