MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PIN,PASSING,DRILL TIP 2.4X381MM,STRL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 7208678

Device Problems Bent (1059); Sticking (1597)

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

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a broach got stuck in the drill.The pin got bent.No consequences for the patient.

Manufacturer Narrative

Visual inspection showed that there were chips missing from the cannulated drill blades and material skived off the passing pin drill¿s outer surface.These chips and material shedding were generated by continued attempt at use and continued rotation of the product after the passing pin bent.The built up grit eventually led to the seizing up of the two products together.Shedding, grit remains were seen after moving the position of the two as received.There were no small pieces returned.Per 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.No root cause related to the manufacture of the device can be established.

• Brand Name: PIN,PASSING,DRILL TIP 2.4X381MM,STRL
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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 w william cannon drive; austin, TX 78735
• MDR Report Key: 7061922
• MDR Text Key: 93084336
• Report Number: 1219602-2017-01486
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 03596010591265
• UDI-Public: (01)03596010591265(17)220518(10)50664992
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7208678
• Device Catalogue Number: 7208678
• Device Lot Number: 50664992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• 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