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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LCP(TM) DISTAL FEMUR PLATE 13 HOLES/316MM RIGHT-STERILE; PLATE,FIXATION,BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH LCP(TM) DISTAL FEMUR PLATE 13 HOLES/316MM RIGHT-STERILE; PLATE,FIXATION,BONE Back to Search Results
Catalog Number 222.258
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Actual event date is unknown.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Pma/510k: device is not distributed in the united states but is similar to device marketed in the usa.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, the patient has broken another lcp distal femur plate.13-hole right lcp df plate incomplete break in distal third of the shaft with plastic deformation.Pt is thought to have metabolic bone disease which lead to a nonunion.There was a revision surgery done in (b)(6) 2019.There was no patient consequence.Concomitant device reported: unk - screws: locking (part# unknown; lot# unknown; quantity 1).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.H6: code 3191 used to capture bone disorder, fracture nonunion and surgical intervention.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 investigation requirements: 5.0mm locking screwself-tapping 80mm (product code: 213.380, lot #: l528658, quantity: 1), 5.0mm locking screw self-tapping 75mm (product code: 213.375, lot #: 7918910, quantity: 1), 5.0mm locking screw self-tapping 75mm (product code: 213.375, lot #: l108563, quantity: 1), 5.0mm locking screw self-tapping 65mm (product code: 213.365, lot #: 2161126, quantity: 2), 5.0mm locking screw self-tapping 55mm (product code: 213.355, lot #: 9875351, quantity: 1), 5.0mm locking screw self-tapping 40mm (product code: 213.340, lot #: l629099, quantity: 1), 4.5mm cortex screw self-tapping 36mm (product code: 214.836, lot #: 9401022, quantity: 1).This report is 1 of 4 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.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
Product complaint # (b)(4).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.E1: reporters state: (b)(6).H3, h4, h6: a review of the device history record has been requested.H3, h6: the investigation could not be completed; no conclusion could be drawn at the time of filing 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.
 
Event Description
Concomitant device reported: 5.0mm locking screwself-tapping 80mm (product code: 213.380, lot #: l528658, quantity: 1), 5.0mm locking screw self-tapping 75mm (product code: 213.375, lot #: 7918910, quantity: 1), 5.0mm locking screw self-tapping 75mm (product code: 213.375, lot #: l108563, quantity: 1), 5.0mm locking screw self-tapping 65mm (product code: 213.365, lot #: 2161126, quantity: 2), 5.0mm locking screw self-tapping 55mm (product code: 213.355, lot #: 9875351, quantity: 1), 5.0mm locking screw self-tapping 40mm (product code: 213.340, lot #: l629099, quantity: 1), 4.5mm cortex screw self-tapping 36mm (product code: 214.836, lot #: 9401022, quantity: 1).
 
Manufacturer Narrative
Product complaint # (b)(4).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.E1: reporters state: (b)(6).H3, h4, h6: a review of the device history record.Device history lot part number: 222.258, synthes lot number: l421628, manufacturing site: mezzovico, release to warehouse date: 19.May 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: investigation summary investigation site: cq zuchwil, selected flow: damaged: visual | examples: deformed/bent/cracked/broken.Visual inspection: the received plate is cracked and deformed at the 4th hole.On one side of the hole is the plate completely apart and on the other side about half of the material is cracked, while the rest is deformed.The plate is in a used condition with discolorations and scratches at different places.Dimensional inspection: thickness.Drawing was reviewed to verify the relevant dimension and the material specification of the plate.The review of the manufacturing documents has shown that with 316l stainless steel for surgical implants the correct material was used.Investigation conclusion: the complaint is confirmed as the received plate is cracked and deformed.During the performed evaluation no manufacturing related issue could be detected, the plate was manufactured according to the specification.Based on the provided information we can only assume that a complication during the healing process, like the mentioned metabolic bone disease with the related non union, did lead a fatigue failure of the plate.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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
LCP(TM) DISTAL FEMUR PLATE 13 HOLES/316MM RIGHT-STERILE
Type of Device
PLATE,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9586647
MDR Text Key194799401
Report Number8030965-2020-00348
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07611819189171
UDI-Public(01)07611819189171
Combination Product (y/n)N
PMA/PMN Number
K062564
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 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number222.258
Device Lot NumberL421628
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2020
Date Manufacturer Received02/26/2020
Patient Sequence Number1
Treatment
CORTSCR Ø4.5 SELF-TAP L36 SST; CORTSCR Ø4.5 SELF-TAP L36 SST; LOCKSCR Ø5 SELF-TAP L40 SST; LOCKSCR Ø5 SELF-TAP L40 SST; LOCKSCR Ø5 SELF-TAP L55 SST; LOCKSCR Ø5 SELF-TAP L55 SST; LOCKSCR Ø5 SELF-TAP L65 SST; LOCKSCR Ø5 SELF-TAP L65 SST; LOCKSCR Ø5 SELF-TAP L65 SST; LOCKSCR Ø5 SELF-TAP L65 SST; LOCKSCR Ø5 SELF-TAP L75 SST; LOCKSCR Ø5 SELF-TAP L75 SST; LOCKSCR Ø5 SELF-TAP L75 SST; LOCKSCR Ø5 SELF-TAP L75 SST; LOCKSCR Ø5 SELF-TAP L80 SST; LOCKSCR Ø5 SELF-TAP L80 SST; UNK - SCREWS: LOCKING
Patient Outcome(s) Required Intervention;
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