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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.210.120S
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/09/2018
Event Type  Malfunction  
Manufacturer Narrative

Patient information is not available for reporting. Due to the intra-operative events, the device was not successfully implanted. As such, implant/explant dates are not applicable. 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. A review of the device history records has been requested and is currently pending completion. 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 europe reports an event in (b)(6) as follows: it was reported that during a surgery for distal radius fracture on (b)(6) 2018, surgeon inserted three (3) screws on the most distal holes for fixation of variable angle (va) tcp small plate 3 holes. After guiding block was taken out from the plate, va locking screw was inserted at a variable angle with the help of variable angle-locking compression plate (va-lcp) drill sleeve; however, the va locking screw could not be tightened at all. The surgeon tried to insert another screw to the same hole of the plate, but it could not be tightened, too. The surgeon thought the thread of plate hole had been damaged, so he decided that the surgery was completed without inserting screw to the hole of plate as he confirmed the plate fixation. Procedure was completed successfully. There was no adverse consequence to the patient and no delay to the surgery. Concomitant device reported: va-lcp drill sleeve (part # unknown, lot # unknown, quantity 1) this is report 1 of 3 for complaint (b)(4).

 
Manufacturer Narrative

Device history records review was completed for part # 04. 210. 120s, lot # l673694. Manufacturing location: (b)(4), release to warehouse date: nov 28, 2017, expiry date: nov 01, 2027. Non-sterile 04. 210. 120, h427058 was manufactured in us, (b)(4), manufacturing location: (b)(4) inc. Packaged by: (b)(4), manufacturing date: oct 23, 2017. Part no: 04. 210. 120, (eu item no. ), lot no: h427058 (non-sterile) certificate of compliance for titanium received from supplier (b)(4) inc. Inspection sheet for incoming final inspection met specification. Components reviewed: raw material part 21015 bp80, lot: 9954218. Certified test report and certificate of test for titanium ingot meet specification. Raw material receiving/ putaway checklist meet requirement. No non- conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Product development investigation was completed. Only one va locking screw was returned for investigation. The visual inspection has shown that the screw in question presents some heavy wear marks on the thread of the screw head as well as on the thread of the screw shaft. The flanks of the threads are rounded and flattened. The anodized rose red color is abraded in all affected areas. The review of the production histories revealed that this locking screw was manufactured in november 2017 according to the specifications. The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements. The certificate of the raw material has been reviewed and indicates that material conforms to specifications. The relevant dimensions could not be checked due to the damage incurred. The condition of the thread on the screw head indicates that it got damaged because of cross-threading or forcible use during insertion. Referring to the statement from the surgeon a possible cause of failure may be a deformed screw hole due to excessive bending of the plate. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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 Name2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7327892
MDR Text Key102118341
Report Number8030965-2018-51899
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK102694
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/09/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number04.210.120S
Device LOT NumberL673694
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/20/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/28/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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