MAUDE Adverse Event Report: SYNTHES MONUMENT 15.0MM CANNULATED DRILL BIT LARGE QC/280MM; BIT, DRILL

Catalog Number 03.010.028

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown.This report is for one (1) unknown cannulated drill bit.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.This report is for one (1) unknown cannulated drill bit.Pma/510(k) number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 devices were used in surgery for distal radius fracture on (b)(6) 2016.It was reported that a patient underwent a procedure on an unknown date.During the procedure a 15.0mm cannulated drill bit broke at the chuck connection.No surgical delay or patient outcome reported.This report is for one (1) unknown cannulated drill bit.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Part 03.010.028, synthes lot 6064460, supplier lot 072613: release to warehouse date: january 14, 2009.Supplier: (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

This was a right trochanteric fixation nail advanced revision procedure that was performed on (b)(6) 2016 due to a nonunion and nail breakage (broke at the point where it intersects with the helical blade).It is unknown how the nail breakage and nonunion were discovered.During the revision the broken nail and all fragments were removed without difficulty.In addition, an intact helical blade and intact distal locking screw were removed without difficulty.The patient was revised to a lateral entry femoral nail.During the revision while drilling the greater trochanter the cannulated drill bit broke at the intersection of the chuck and drill bit.The power source was a stryker 7000 power drill.No fragments fell into the patient and all fragments were removed from the surgical field.The procedure was successfully completed with a different readily available synthes drill bit and routine, planned x-rays were taken.There was no surgical delay, additional medical intervention or unanticipated x-rays performed.There was no patient harm reported.Post-operatively, the surgeon reported the patient is healing as expected.Concomitant devices reported: distal locking screw (part/lot unknown, quantity 1); 8.5mm helical blade (part/lot unknown, quantity 1); trochanteric fixation nail advanced (tfna) nail 130 degree right (11 x 320) (part 04.037.152s, lot 9983624, quantity 1); standard 3.2 starting pin (part 357.399, lot unknown, quantity 1); and stryker 7000 power drill (part/lot unknown, quantity1).This report is to capture the broken drill bit during the revision procedure.The broken nail, non-union and need for the revision procedure are being captured in linked complaint (b)(4).

Manufacturer Narrative

A product development investigation was performed on the returned device (15.0mm cannulated drill bit large qc/280mm, part # 03.010.028, lot # 072613).This complaint is confirmed.A portion of the proximal end of the returned drill bit has sheared off and was not returned for evaluation.The overall length of the returned drill bit measures approximately 261mm.Therefore, the length of the sheared off proximal shaft portion that was not returned would be approximately 19.0mm in length with reference to overall drill bit length specification of 279.0mm - 281.0mm per product drawing.The outside shaft diameter at the location nearest the breakage measures 5.70mm which is within specification per product drawing.The inside shaft diameter/cannulation at the location nearest the breakage measures 3.85mm which is within specification per product drawing.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.Most likely due to application of off axis force causing the cannulated drill bit the shear at the location of its smallest material cross section.A visual inspection under 5x magnification, dimensional inspection, device history record (dhr) review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The returned 15.0mm cannulated drill bit large qc/280mm (part# 03.010.028) is a reusable instrument in the titanium cannulated lateral entry femoral recon nail system used to open the medullary canal.This complaint is confirmed.A portion of the proximal end of the returned drill bit has sheared off and was not returned for evaluation.Drawing was reviewed during this evaluation.No product design issues or discrepancies were observed.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.

• Brand Name: 15.0MM CANNULATED DRILL BIT LARGE QC/280MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6195808
• MDR Text Key: 63084159
• Report Number: 2520274-2016-15738
• 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,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.028
• Device Lot Number: 072613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2009
• 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