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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 130 DEG LCP DHS PLATE-STANDARD BARREL 6 HOLES/124MM-STERILE; PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 130 DEG LCP DHS PLATE-STANDARD BARREL 6 HOLES/124MM-STERILE; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.224.206S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/27/2020
Event Type  malfunction  
Manufacturer Narrative
Additional device product codes: ktt.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during an under right trochanteric fracture procedure, when checking the material before implantation the screw did not fit on the plate.Another plate and screw were used to complete the surgery.There was no consequence to the patient.Concomitant devices reported: dhs/dcs lag screw 12.7mm thread/100mm-sterile (part number 280.000s, lot 28p2041, quantity 1).This report involves one (1) 130 deg lcp dhs plate-standard barrel 6 holes/124mm-sterile.This is report 2 of 2 for (b)(4).This product complaint, (b)(4), is related to (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: a product investigation was conducted.Visual inspection: the visual inspection has shown that the plate is intact and in general in a very good condition, there are no damages at the screw interface visible.Investigation conclusion: the complaint is confirmed as it is impossible to assemble the received plate and screw as complained.The cause of this malfunction can be clearly traced back to a deformation at the screw.There is no indication that the plate did contribute to complained malfunction.The root cause was identified during the performed cq evaluation of the also received dhs/dcs screw and therefore the in the investigation flow listed remaining investigation steps are not required for 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.H3, h4, h6: a device history record (dhr) review was conducted: part: 02.224.206s , lot: 6l14236 , manufacturing site: grenchen, release to warehouse date: 05 november 2019 , expiry date: 01 october 2029.A manufacturing record evaluation was performed for the finished device part: 02.224.206s , lot: 6l14236, and no non-conformances related to malfunction were identified.The nonconformance refered within the dhr is a planned one, that was aimed to monitor and control specific activities to manage all work orders (wo)) which were in wip, during the cutover phase for the transition from old erp (sap p01) to the new erp (sap p02).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
130 DEG LCP DHS PLATE-STANDARD BARREL 6 HOLES/124MM-STERILE
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10152928
MDR Text Key195093375
Report Number8030965-2020-04148
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07611819821002
UDI-Public(01)07611819821002
Combination Product (y/n)N
PMA/PMN Number
K791619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02.224.206S
Device Lot Number6L14236
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2020
Initial Date Manufacturer Received 06/02/2020
Initial Date FDA Received06/15/2020
Supplement Dates Manufacturer Received06/16/2020
Supplement Dates FDA Received06/30/2020
Patient Sequence Number1
Treatment
DHS/DCS-SCR Ø12.5 L100 SST; DHS/DCS-SCR Ø12.5 L100 SST
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