MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6MM/9MM CANNULATED STEPPED DRILL BIT; BIT,DRILL

Model Number 03.037.022

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on an unknown date, during drilling lateral cortex with the 6/ 9 mm stepped reamer for insertion of proximal femoral nailing system (tfna) lag screw, after drilling, there were a few specs on x-ray, checked the drill bit, and there were two (2) pieces of the tip of reamer that had broken off into the bone.Fragments not removed.Action was taken when the event occurred continued on to finish the case.There was no surgical delay reported.The procedure was successfully completed.There were no patient consequences.Concomitant devices reported: unknown nails: tfna (part # unknown, lot # unknown, quantity# 1), unknown powered drivers/handpieces (part # unknown, lot # unknown, quantity# 1).This complaint involves one (1) device.This report is for one (1) 6 mm/ 9 mm cannulated stepped drill bit.This is report 1 of 1 for (b)(4).

• Brand Name: 6MM/9MM CANNULATED STEPPED DRILL BIT
• Type of Device: BIT,DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9559040
• MDR Text Key: 173961767
• Report Number: 2939274-2020-00077
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10886982070388
• UDI-Public: (01)10886982070388
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.022
• Device Catalogue Number: 03.037.022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - NAILS: TFNA; UNK - POWERED DRIVERS/ HANDPIECES