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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 10MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH 10MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 456.314S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 03/23/2018
Event Type  Injury  
Manufacturer Narrative
Patient¿s identifier, gender and weight are not available for reporting. Additional device product code: hwc. Due to the intra-operative events, the device was not successfully implanted. An alternate device was used to complete procedural step. 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. (b)(4) used to capture change in surgical plan: the surgeon used another nail from another lot to complete the procedure with a reported delay of 20 minutes. 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 the it was impossible to lock the nail with the locking screw during a surgery performed on (b)(6) 2018. It was impossible to insert the superior locking screw. There was twenty (20) minutes of surgical delay due to the reported issue. Another nail was used to complete the procedure. The surgery was completed successfully without any harm to the patient. Concomitant devices reported: bolt ø4. 9 self-tap l34 tan green (part # 459. 340s, lot # unknown, quantity 1), guidewire ø3. 2 f/pfna blade (part # 356. 830s, lot # unknown, quantity 1). This report is for one (1) 10mm/125 deg ti cann troch fixation nail 170mm-sterile. This is report 1 of 2 for complaint (b)(4).
 
Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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 Name10MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7447735
MDR Text Key106088245
Report Number8030965-2018-53266
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K011857
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,Followup,Followup
Report Date 03/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number456.314S
Device Lot NumberH461238
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/20/2018 Patient Sequence Number: 1
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