MAUDE Adverse Event Report: SYNTHES USA 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION; BIT, DRILL

Catalog Number 03.010.061

Device Problem Failure to Align (2522)

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

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation, as it was reportedly discarded by the facility.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient underwent a short advanced proximal femoral nailing system (tfna) procedure on (b)(6) 2016 to treat a right hip fracture.During the procedure the drill bit for the distal locking screw drilled posterior to the nail instead of through the center of the nail hole; it missed the hole through the drill guide.The standard aiming arm and drill sleeves were used for the procedure.The surgeon removed the screw and performed a free hand screw insertion.This event resulted in a thirty (30) minute delay.No patient harm was reported.Routine x-rays were taken during the procedure, no findings reported.The surgeon checked that all components were tight and secure within the instrumentation.The procedure was successfully completed.Concomitant devices reported: cannulated connecting screw (part 03.037.010, lot 9343561, quantity 1); stardrive screwdriver/t25 self retaining/ 319mm (part 03.010.518, lot 9067822, quantity 1); stardrive screwdriver/t25 (part 314.118, lot 7910805, quantity 1); 11.0mm/8.Omm protective sleeve 188mmfor asla (part 03.025.040, lot 9156288, quantity 1); 8.0mm/4.2mm drill sleeve 200mm (part 03.010.065, lot 9144868, quantity 1); aiming arm (part 03.037.013, lot 9431065, quantity 1); insertion handle (part 03.037.011, lot 9910361, quantity 1); screw (part/lot unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis please note that the device (drill bit part# 03.010.061 lot unknown) was not returned; the following concomitant devices were returned: cannulated connecting screw: part 03.037.010, lot# 9343561, quantity x1.Stardrive screwdriver/t25 self retaining/ 319mm: part 03.010.518, lot# 9067822, quantity x1.11.0mm/8.Omm protective sleeve 188mm for asla: part 03.025.040, lot# 9156288, quantity x1.8.0mm/4.2mm drill sleeve 200mm: part 03.010.065, lot# 9144868, quantity x1.Aiming arm: part 03.037.013, lot# 9431065, quantity x1.Insertion handle: part 03.037.011, lot# 9910361, quantity x1.Per the complaint description no complaint allegations were made against these devices and upon visual inspection.No issues were noted therefore no further investigation is required.A drawing review and dhr could not be done for the part because the device was not returned and the lot number is unknown respectively.Due to the tight tolerances and design, the construct(s) is susceptible to lateral forces during the surgery that are unable to be replicated in the cq.It is likely that soft tissue distractions forces are the cause of this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6205247
• MDR Text Key: 63368295
• Report Number: 2520274-2016-15772
• Device Sequence Number: 1
• Product Code: HTW
• 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
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2017
• 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: 1 PART 03.010.065, LOT 9144868, DRILL SLEEVE; 1 PART 03.010.518, LOT 9067822, SCREWDRIVER; 1 PART 03.025.040, LOT 9156288, PROTECTIVE SLEEVE; 1 PART 03.037.010, LOT 9343561, CONNECTING SCREW; 1 PART 03.037.011, LOT 9910361, INSERTION HANDLE; 1 PART 03.037.013, LOT 9431065, AIMING ARM; 1 PART 314.118, LOT 7910805, SCREWDRIVER; 1 UNKNOWN SCREW
• Patient Age: 75 YR
• Patient Weight: 91