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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LCP® RECONSTRUCTION PLATE 7 HOLES/98MM; APPLIANCE,FIXATION,NAIL
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OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LCP® RECONSTRUCTION PLATE 7 HOLES/98MM; APPLIANCE,FIXATION,NAIL Back to Search Results
Catalog Number 445.071
Device Problems Crack (1135); Material Discolored (1170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2018
Event Type  malfunction  
Manufacturer Narrative
Occupation: reporter is synthes employee photo review was conducted: the photos show one lcp recoplate 3.5 straight w/combined hole which was bent in various areas.The plate is covered with marks and notches and the golden color has discolored in different areas.The complaint therefore is confirmed.A review of the device history records has been requested.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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported during an unknown surgery on (b)(6) 2018, a locking compression plate (lcp) was found to have metal discoloration and damage.The surgeon thought the discoloration would not matter, so the device was continued to be used, however, during the screwing of the pad, the plate was damaged.Another device was used to complete the surgery.It was unknown if there was a surgical delay.There was no adverse consequence to the patient reported.Concomitant device reported: screw (part # unknown, lot # unknown, quantity # unknown).This report is for one (1) 3.5mm ti lcp® reconstruction plate 7 holes/98mm.This is report 1 of 1 for complaint (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 the information is unknown, not available or does not apply, the section/field of the form is left blank.Visual appearance: the plate is bent in all axis and has a crack at hole a2.The crack does not go completely through the plate, see, image 1, image 2, image 3 and image 4.There are several dings and dents on the surface.The anodized golden layer is not even around the surface, there are silver areas on the entire surface except around the hole b4.The silver areas on the top and bottom side between the holes are geometrically formed.They look like an oval ring with two round dots inside just next to the plate¿s holes.This is especially visible at the bottom side between holes b1 and b2 and between the holes b2 and b3.The recon-notches on the convex side of the plate are also silver, except between b3 and b4.At this end the plate is not bent and the anodized layer shows the least damage.All holes and threads are visible deformed and not round.Investigation of critical features on complaint part: the critical features cannot be verified on the complaint part due to its deformation.Conclusion: the plate with article number 445.071 (lcp recopl 3.5 straight w/combined hole) with the lot number l932987 was produced as it intended.The investigation and 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 plate met fully to the specifications when manufactured and distributed.All damage and discoloration were caused during use.Therefore, the complaint is confirmed but not valid from a manufacturing point of view.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 history lot part: 445.071 lot: l932987 manufacturing site: raron release to warehouse date: 14 june 2018.The device history record shows this lot 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.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
3.5MM TI LCP® RECONSTRUCTION PLATE 7 HOLES/98MM
Type of Device
APPLIANCE,FIXATION,NAIL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8274366
MDR Text Key134061201
Report Number8030965-2019-60249
Device Sequence Number1
Product Code KTT
UDI-Device Identifier07611819242425
UDI-Public(01)07611819242425
Combination Product (y/n)N
PMA/PMN Number
K000684
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 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number445.071
Device Lot NumberL932987
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2019
Date Manufacturer Received02/14/2019
Patient Sequence Number1
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