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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI MATRIXMANDIBLE DOUBLE ANGLE RECON PL SMALL 2.5MM THICK; PLATE, BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH TI MATRIXMANDIBLE DOUBLE ANGLE RECON PL SMALL 2.5MM THICK; PLATE, BONE Back to Search Results
Catalog Number 04.503.741S
Device Problem Break (1069)
Patient Problems Erosion (1750); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 (b)(6) 2019, the patient underwent the exarticulation of mandible surgery.During the procedure, the resection part was wide, and the surgeon had difficulty in bending the plate.After the surgery, on an unknown date, the surgeon confirmed that the plate was broken.On (b)(6) 2020, the patient underwent the revision surgery by replacing the plate with a new one.The plate penetrates from the skin now.No further information is available.Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown).This report is for one (1) ti matrixmandible double angle recon pl small 2.5mm thick 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.H3, h6: sterile part part: 04.503.741s, lot: 1l65337, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: september 27, 2018, expiry date: september 1, 2028.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: non-sterile part part: 04.503.741, lot: h656938, manufacturing site: monument.14-apr-2020 by: mschoenfeld a dhr review was not performed for this pi.This lot was manufactured by elmira.Please reassign this task to the correct group.Product was not returned.Based on the information available, it has been determined that no corrective and 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.
 
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: a product investigation was conducted: investigation site: cq zuchwil, selected flow: damaged.Visual inspection: the plate is broken exactly at the middle.(13th hole form left & right).Furthermore, on several areas of the plate are deep scratches and impression marks which were caused most probably from the bending tool.All features related to the reported complaint condition were reviewed and no other issues were identified.Drawing/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Furthermore, as indicated in the manufacturing documents, the correct material was used according iso 5832-2.The broken surface is homogenous what indicates material conformity as well.Summary: the complaint condition is confirmed as the plate was found broken.This lot was manufactured in september 2015 and we are not aware of any other complaint for this part- and lot number combination.This and the findings above let us exclude a manufacturing related issue.Based on the provided information we are not able to determine the exact cause of this breakage.We can only assume that any occurrence during the healing process, e.G.Non-union, delayed union, mal-union, overloading of the osteosynthesis or a combination of different factors, did lead to a fatigue failure.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.H3, h4, h6: a device history record (dhr) review was conducted: sterile part part: 04.503.741s, lot: 1l65337, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: sept.27, 2018, expiry date: sept.01, 2028.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: non-sterile part: 04.503.741, lot: h656938, manufacturing site: monument.Apr 14, 2020.A dhr review was not performed for this pi.This lot was manufactured by elmira.Device history review done on july 27, 2020.Part number: 04.503.741, lot number: h656938, part manufacture date: june 06, 2018 , manufacturing location: elmira, part expiration date: n/a, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of ti matrix mandible double angle recon plate was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.The lot quantity of 14 pieces met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the device history record for the raw material revealed no complaint related anomalies.The device history record shows this lot met all requirements at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history review the lot quantity of 14 pieces met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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
Concomitant device reported: screws (part number unknown, lot unknown, quantity 10).
 
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 was 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.
 
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.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, h4, h6: 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.
 
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.H10 additional narrative: d4: lot.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
TI MATRIXMANDIBLE DOUBLE ANGLE RECON PL SMALL 2.5MM THICK
Type of Device
PLATE, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9991814
MDR Text Key194153380
Report Number8030965-2020-03075
Device Sequence Number1
Product Code JEY
UDI-Device Identifier07611819980754
UDI-Public(01)07611819980754
Combination Product (y/n)N
PMA/PMN Number
K063790
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.503.741S
Device Lot Number1L65337
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2020
Date Manufacturer Received08/28/2020
Patient Sequence Number1
Treatment
UNK - SCREWS: MATRIXMANDIBLE.; UNK - SCREWS: MATRIXMANDIBLE.; UNK - SCREWS: MATRIXMANDIBLE.
Patient Outcome(s) Required Intervention;
Patient Age71 YR
Patient Weight27
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