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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SHAFT F/AWL F/04.630.135S

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OBERDORF SYNTHES PRODUKTIONS GMBH SHAFT F/AWL F/04.630.135S Back to Search Results
Catalog Number 03.630.144
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/18/2018
Event Type  Injury  
Manufacturer Narrative
Patient information was not provided for reporting. Device is an instrument and is not implanted / explanted. Device is expected to be returned for manufacturer review/investigation, but has not been received yet. Reporter facility contact number was not provided. Device is not distributed in the united states, but is similar to device marketed in the usa. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Additionally, device history records review could not be completed without lot number. 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 on (b)(6) 2018, during the surgery, it was noted that the handle for the awl that prepares the bone bed for screw insertion was missing from the loan tray. The surgeon subsequently tried to use it without the handle but the tip of the shaft snapped off in patient. This could not be retrieved and was left in the patient. Surgery and patient outcome were not reported. This report is for one (1) shaft f/awl f/04. 630. 135s. This is report 1 of 1 for (b)(4).
 
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Brand NameSHAFT F/AWL F/04.630.135S
Type of DeviceAWL
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 Key7512379
MDR Text Key108227469
Report Number8030965-2018-53750
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodeUK
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 04/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.630.144
Device Lot Number1502741
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/14/2018 Patient Sequence Number: 1
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