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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 6.5MM TI RECON SCREW WITH T25 STARDRIVE 75MM-STERILE ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH 6.5MM TI RECON SCREW WITH T25 STARDRIVE 75MM-STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.003.025S
Device Problem Difficult to Advance (2920)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 06/20/2020
Event Type  Injury  
Manufacturer Narrative
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. (b)(4). 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 femoral shaft fracture with the screw. During the surgery, the surgeon could not insert the screw properly. The surgeon drilled again, and tried to insert the screw, but he couldn¿t insert it properly. The surgeon changed the surgical technique to standard locking, and the surgery was completed successfully with a thirty (30) minute delay. The patient was reported as stable after the procedure. Concomitant device reported: drill (part number unknown, lot unknown, quantity unknown). This report involves one (1) 6. 5mm ti recon screw with t25 stardrive 75mm-sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name6.5MM TI RECON SCREW WITH T25 STARDRIVE 75MM-STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
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 Key10223530
MDR Text Key197314455
Report Number8030965-2020-04617
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172157
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.003.025S
Device Lot Number4L07130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2019
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: 07/02/2020 Patient Sequence Number: 1
Treatment
UNK - DRILL
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