SYNFRAME HALF RING 387.337

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for SYNFRAME HALF RING 387.337 manufactured by Oberdorf Synthes Produktions Gmbh.

Event Text Entries

[186553572] The visual inspection of the returned synframe half ring has shown that the locking screw is damaged at the threaded shaft as well the hexagonal recess is badly widened. All in all the device is in very used condition and there are wear marks and scratches visible all over the surface. A functional test cannot be performed of the detected damage. The damaged thread of the locking screw prevent a proper tightened of the connection with the other synframe half ring. The received condition agree with the complaint description and the complaint therefore is confirmed. The investigation has shown that the locking screw is damaged at the threaded shaft as well the hexagonal recess is badly widened. All in all the device is in very used condition and there are wear marks and scratches visible all over the surface. The damaged thread of the locking screw prevent a proper tightened of the connection with the other synframe half ring. The damage incurred is determined to be post production. The damaged locking screw is a clear indication, that the product was used in an excessive way over the years. We do suppose that the cause of the damages are the result of a several mechanical overload situation during use. 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. The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps "dimensional inspection:" are not required. 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: 50131166 lot: 1941932 manufacturing site: (b)(4) release to warehouse date: 08. July. 2008 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. 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.
Patient Sequence No: 1, Text Type: N, H10


[186553573] Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the synframe sent had a damaged part on it. The synframe has a large ring which is held together by screws on its diameter. There is an issue with the locking screws that means the ring was not stable during use. No patient involvement reported. This report is for one (1) synframe half ring this is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030965-2020-02399
MDR Report Key9897585
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-02
Date of Event2020-02-10
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1WERK H
Manufacturer StreetIM BIFANG 6
Manufacturer CityHAEGENDORF 4614
Manufacturer CountrySZ
Manufacturer Postal Code4614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYNFRAME HALF RING
Generic NameORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Product CodeLXH
Date Received2020-03-30
Returned To Mfg2020-02-27
Catalog Number387.337
Lot Number1941932
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOBERDORF SYNTHES PRODUKTIONS GMBH
Manufacturer AddressEIMATTSTRASSE 3 OBERDORF 4436 SZ 4436


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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