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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DIRECT MEASUR-DEVICE F/GUIDEWIRES 2+2.8; GAUGE,DEPTH
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OBERDORF SYNTHES PRODUKTIONS GMBH DIRECT MEASUR-DEVICE F/GUIDEWIRES 2+2.8; GAUGE,DEPTH Back to Search Results
Catalog Number 319.700
Device Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Investigation summary: complained issue could be replicated, based on the received picture.Please note, the direct measuring device shows the length for the complete cannulated screw including the screw head, therefore the result is 5mm higher than the depth in original measured.Please follow to surgical technique for cannulated screws.Based on this the complaint is classified as not confirmed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Product was not returned.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 (information or/and material), 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, reports an event in (b)(6) as follows: it was reported that, on an unknown date, by nursing staff at (b)(6) that direct measure (ref: 319.700) for set 6.5/7.3 is not reading accurately.Upon testing direct measure it appeared out by 5mm.No impact to the patient.Guide wire.Lot: 7632630.Concomitant device reported: unknown guide wire (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.This report is for one (1) ann screw measuring device or 6.5mm & 7.3mm cann screws.This is report 1 of 1 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.A product investigation was conducted.Visual inspection: upon visual inspection of the complaint device it can be seen that the instrument is in a used condition with impression marks and scratches all over, which is an indication of regular use through its more than 8 years of lifespan.The received direct measuring device is in used but still faultless condition.Document/specification review: drawings and revisions are in accordance to dhr of production lot 7632630.All relevant features are defined on the used drawing revisions of dhr of production lot 7632630.Summary: a device history record (dhr) review was performed for the affected lot, 12 parts were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure.The article was manufactured in december 2011.No ncrs were marked in the dhr during production.Moreover, a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.There is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we assume that during the operation an application error may have taken place.Please note, the direct measuring device shows the length for the complete cannulated screw including the screw head, therefore the result is 5mm higher than the depth in original measured.Please strictly follow to surgical technique dsem/trm/0714/0110(3) 02/17 for cannulated screws.The received device is in complete faultless condition and no product fault could be identified, therefore the in the investigation flow listed remaining investigation steps are not required.Therefore, we cannot replicate the complained condition.This complaint is classified as not confirmed.No further investigations are required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.A device history record (dhr) review was conducted: part: 319.700, lot: 7632630, manufacturing site: hägendorf, release to warehouse date: 05.December 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
DIRECT MEASUR-DEVICE F/GUIDEWIRES 2+2.8
Type of Device
GAUGE,DEPTH
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9510628
MDR Text Key194148553
Report Number8030965-2019-71347
Device Sequence Number1
Product Code HTJ
UDI-Device Identifier07611819064850
UDI-Public(01)07611819064850
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
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number319.700
Device Lot Number7632630
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2020
Date Manufacturer Received06/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK - GUIDE/COMPRESSION/K-WIRES
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