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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 03.033.002
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Initial reporter is synthes sales consultant. Dhr review was completed. Part: 03. 033. 002. Lot: l750748. Manufacturing site: (b)(4). Release to warehouse date: (b)(6) 2018. The device history record shows this lot of 11 pieces was processed through the normal manufacturing and inspection operations with no rework or relevant nonconformities noted. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process. Only top level of the device history record reviewed as sub-components are not lot tracked. Further review has shown that the non-conformity was created as one piece of this lot did get damaged on the transportation between haegendorf and monument. The damaged piece has been discarded and the remaining 11 pieces were re-inspected and no damage was detected. Therefore it is unlikely that this transportation damage is relevant for the complaint condition. However, a final conclusion is only possible after a physical evaluation of the device. 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
It was reported that on (b)(6) 2018, while assembling the set for the first time, the radiolucent aiming arm was found broken in the original package. There was no patient or surgical involvement. This report is for one (1) radiolucent aiming arm. This is report 1 of 1 for pc-(b)(4).
 
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Brand NameRADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8119320
MDR Text Key128930272
Report Number2939274-2018-55179
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172157
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number03.033.002
Device Catalogue Number03.033.002
Device Lot NumberL750748
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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