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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 40MM PLATE,FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 40MM PLATE,FIXATION,BONE Back to Search Results
Catalog Number 04.211.040S
Device Problem Break (1069)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 08/17/2020
Event Type  Injury  
Manufacturer Narrative
Additional procode: hwc. (b)(4). 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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent a surgery for distal humerus with the screw in question. During the surgery, after the surgeon inserted the screw halfway with a power tool, the surgeon tried to insert the screw completely with a screwdriver, but he could not turn the screw. The surgeon confirmed by image intensifier that the tip of the screw was out of the bone. He tried to remove it but the screw was not turned because the screw was idling and there was a cracking sound. While touching the tip of the screw the surgeon turned the screw with the screwdriver, but the tip of the screw was not turned. When the surgeon removed the screwdriver, only the screw head was held with the screwdriver, and the screw shaft remained in the bone. The surgeon removed the screw shaft with the kochel forceps. The surgery was completed successfully with a thirty (30) minute delay. No further information is available. Concomitant device reported: unknown screwdriver (part # unknown, lot # unknown, quantity 1), unknown power tool device (part # unknown, lot # unknown, quantity 1), unknown screws (part # unknown, lot # unknown, quantity unknown), unknown plate (part # unknown, lot # unknown, quantity unknown). This report is for one (1) 2. 7mm ti va lckng scr slf-tpng with t8 stardrive recess 40mm. This is report 1 of 1 for (b)(4).
 
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Brand Name2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 40MM
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
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10524824
MDR Text Key212125359
Report Number8030965-2020-06877
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K100776
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.211.040S
Device Lot Number6L53573
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/11/2020 Patient Sequence Number: 1
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