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

Catalog Number 7208678

Device Problems Break (1069); Component Falling (1105)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an acl reconstruction, the pin broke when the surgeon tried to make the hole.The broken tip was removed from the joint using kocher.A backup device was utilized to complete the procedure and patient injury or complications were reported.

Manufacturer Narrative

One 7208678 2.4x381mm sterile drill tip passing pin returned.The distal spiral flutes are not damaged.The pin is sheared into two sections.The damages acquired are between the 20mm and 44mm section.There are gouges in the surface material as well as scratches and teeth marks.It is unknown whether these occurred during drilling or the subsequent removal of the broken portion with a kocher forceps instrument.There is a bow in the portion distal to the break.There does seem to have been a point of over torque.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 dr.; austin, TX 78735 ; 5123585706
• MDR Report Key: 6298800
• MDR Text Key: 66666815
• Report Number: 1219602-2017-00146
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7208678
• Device Lot Number: 50611147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• 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
• Patient Age: 30 YR