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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CANNULATED SCREW MEASURING DEVICE FOR 3.5MM & 4.0MM; GAUGE, DEPTH
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OBERDORF SYNTHES PRODUKTIONS GMBH CANNULATED SCREW MEASURING DEVICE FOR 3.5MM & 4.0MM; GAUGE, DEPTH Back to Search Results
Catalog Number 319.150
Device Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2018
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 unknown surgical procedure on an unknown date, the cannulated screw measuring device was discovered to be measuring 2.5mm too long.It was noted that the threaded guide wire (kirschner wire) was the right sort and was used as it was the correct length.A new cannulated screw measuring device was ordered and received the same result of measuring 2.5mm too long.No patient consequence was reported.Concomitant devices: cannulated screw (part unknown, lot unknown, quantity 1), 1.25mm threaded guide wire 150mm (292.620, lot unknown, quantity 1).This report is for one (1) cannulated screw measuring device.This is report 1 of 2 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative event: updated event description.Concomitant medical products.Device evaluated by mfr: 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.
 
Event Description
11/19/2018: updated event description: it was reported that on (b)(6) 2018, during an unknown procedure, the direct measuring device was used for the first time to a new placement cannulated screw and was discovered that measuring was too long.It was noted that the k-wire with the right sort where used and was the correct length.A new direct measuring device was ordered and showed exactly the same result, which was too long.There was no patient consequence reported.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Therapy date a device history record (dhr) review was conducted: part: 319.150 lot: 9894649 manufacturing site: hägendorf release to warehouse date: 06.Jun.2016 the device history record shows this lot of 23 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.H3, h6: a product investigation was conducted.Summary of the manufacturing evaluation: the shipped back instrument 319.150 ¿direct measur-device f/cannscr ø3.5+4¿ is in new not used look condition.The dimensional inspection was provided for the shipped back article in accordance with the inspection sheet, valid at the time.The features witch was defined as critical to quality was measured and documented in chapter 2.4 dimensional inspection of this form.According the executed dimensional inspections, according at the time valid inspection sheet, all measurements passed the dimensional inspection and the expected results were achieved.No manufacturing related issue was identified and/or confirmed.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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.
 
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Brand Name
CANNULATED SCREW MEASURING DEVICE FOR 3.5MM & 4.0MM
Type of Device
GAUGE, DEPTH
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8075420
MDR Text Key127548694
Report Number8030965-2018-58264
Device Sequence Number1
Product Code HTJ
UDI-Device Identifier07611819020818
UDI-Public(01)07611819020818
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 10/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number319.150
Device Lot Number9894649
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2018
Date Manufacturer Received01/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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