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

Catalog Number 323.034

Device Problem Difficult to Advance (2920)

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

Event Date 03/02/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: device is an instrument and is not implanted/explanted.(b)(6).A device history record (dhr) review was performed on part # 323.034, lot # 8859277: manufacturing site: (b)(4), manufacturing date: 26.Feb.2014.No non conformance reports (ncrs) 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.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during surgery it was not possible to screw the drill sleeve into the plate.The thread of the plate does not seem to be affected and other instruments were able to screw into the plate.There is possible damage to the drill sleeve.The surgery was not prolonged.There was no patient harm reported and the surgery was successfully completed.The locking compression plate (lcp) plate was implanted in the patient.Concomitant device reported: 2.0mm ti lcp(tm) plate 5 holes/38mm (part # 447.345, lot # unknown, quantity 1).This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: manufacturing evaluation was completed.One part# 323.034, was received for manufacturing investigation.The article is in a used condition.Traces of use are present on the part surface.During the manufacturing investigation the part no 323.034 was checked with functional gage.The measured thread zero point of the lcp drill sleeve 323.034 has an actual value of -0.05 mm and is within specification of +0.15mm/-0.15mm as defined on the product drawing.Therefore the thread of lcp drill sleeve 323.034 will fit into the implant plate holes.There were no references to the reported issue.No manufacturing related issue was identified and/or confirmed, 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.

Manufacturer Narrative

A product investigation was completed: since no manufacturing related conditions were found we determine this complaint as unconfirmed.Unfortunately we are not able to determine the exact cause of this complaint.A possible reason for the issue could be that the drill sleeve was not correctly aligned.Since no manufacturing related conditions were found we determine this complaint as unconfirmed.No indication for product related issue was found.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 CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6427692
• MDR Text Key: 70758630
• Report Number: 3003875359-2017-10136
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819156586
• UDI-Public: (01)07611819156586(10)8859277
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 323.034
• Device Lot Number: 8859277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2014
• 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: PLATE (PART # 447.345, LOT # UNKNOWN, QUANTITY 1)