MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DEPTH GAUGE FOR 3.5MM CORTEX SCREWS; GAUGE,DEPTH

Catalog Number 319.091

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Device is an instrument and is not implanted/explanted.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during an invasive surgical procedure for ilium-wing fractures on (b)(6) 2018, it was noted the inner scale on the inside of the outer cylinder of the depth gauge for 3.5mm cortex screws was very hard to slide.It was suspected this was due to unnecessary contact between the two (2) components.Surgery was completed successfully with no delay and not adverse consequence to the patient.Patient status reported as stable.This report is for one (1) depth gauge for 3.5mm cortex screws.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part# 319.091, lot# 6414742.Manufacturing location: (b)(4), release to warehouse date: jun 22, 2010.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.The returned depth gauge shows several mechanical damages on the surface.Furthermore, the anodized color was found partially disappeared.The returned depth gauge was tested and the complaint condition could be confirmed, as it is rough running as reported.The instrument was lubricated with synthes special oil during the investigation and was then freely movable as required.The problem as per complaint description could not be duplicated anymore.Investigation has shown that the complaint condition is confirmed.It is assumed that the instrument was not lubricated as per the instructions provided by the manufacturer.Based on these findings, it was concluded that the cause of failure was not due to any manufacturing non-conformances.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: DEPTH GAUGE FOR 3.5MM CORTEX SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7425181
• MDR Text Key: 105297143
• Report Number: 8030965-2018-53040
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819796928
• UDI-Public: (01)07611819796928(10)6414742
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.091
• Device Lot Number: 6414742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1