MAUDE Adverse Event Report: SYNTHES HAGENDORF 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE

Catalog Number 323.034

Device Problems Failure to Advance (2524); Difficult to Advance (2920)

Patient Problem No Patient Involvement (2645)

Event Date 04/27/2015

Event Type  malfunction  

Event Description

It was reported that a quantity of two (2) threaded drill guides are not functioning properly.A demonstration with a brand new locking compression plate (lcp) mini-set was being done with a surgeon on (b)(6) 2015.The drill guides for the thread would not pass through to any of the locking holes on the 2.0 lcp plates.A second set was available at the time ¿ the drill guides from that set worked on the plates from the first; therefore, no allegations are being made against the plate.No additional information is available at this time.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history review: manufacturing location: (b)(4) - manufacturing date: august 12, 2014.No anomalies were detected during device history record review.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device 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.

Manufacturer Narrative

A manufacturing evaluation was completed: received 1 article of lcp drill sleeve 2.0, with scale, for drill bits ø 1.5 mm, part# 323.034 for manufacturing investigation.The thread of the drill sleeve has no visible damage.It was reported that a quantity of two of item 323.034 aren't functioning properly.This is a brand new lcp mini set which was received by the sales consultant last week and when he was showing it to the surgeon on (b)(6) 2015; he could not get the drill guides to thread into any of the locking holes in the 2.0 lcp plates.A second set was available at that time and the same drill guides from the 2nd set worked fine on the same plate that just failed.The sales consultant confirmed there are no allegations of deficiency against the plate.Another set was used on the same plate and it functioned as expected.The sales consultant confirmed there is no additional information to be provided at this time.The lot number 9093905 is the same on both drill guides.During the manufacturing investigation, the thread of the drill sleeve was tested and measured with the function gage 60018217.The measured thread tolerance was within the specification.The thread of the drill sleeve is ok.There are no references to the reported issue.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: 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE
• Type of Device: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4772431
• MDR Text Key: 5785817
• Report Number: 3003875359-2015-10213
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 323.034
• Device Lot Number: 9093905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1