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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4/2.7MM TI VA LCKNG X-PLATE EXTRA SMALL-STERILE PLATE,FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.4/2.7MM TI VA LCKNG X-PLATE EXTRA SMALL-STERILE PLATE,FIXATION,BONE Back to Search Results
Catalog Number 04.211.201S
Device Problems Break (1069); Device Operational Issue (2914)
Patient Problem Not Applicable (3189)
Event Date 01/25/2018
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient age not provided for reporting. Additional product code: hwc. Not explanted. Device is not expected to be returned for manufacturer review/investigation. (b)(6). The investigation could not be completed; no conclusion could be drawn, as no product was received. Investigation summary: the manufacturing documents were reviewed and no complaint related issues were found. Product was not returned, therefore no further investigation is possible. Based on the information available, 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. 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 on an event in (b)(6) as follows: on (b)(6) 2018, this implant was used in the surgery for hallux valgus(left). X-pl-2. 4/2. 7 va lock xs 23. 5*15 tan. During the surgery, two surgeons were involved in bending of this plate. One surgeon held the plate while the other surgeon bent it. One screw hole of the plate broke while bending, they tried to use another size of the plate, but it was too big to be implanted. The broken plate was used by inserting a cortical screw and the surgical incision was closed. Surgery was completed with a 10-minute delay. There was no adverse consequence to the patient. Post-operative condition of the patient and the fixation of the broken plate are both good. This complaint involves 1 part. Plate other size (part# unknown / lot# unknown / quantity 1), cortical screw (part# unknown / lot# unknown / quantity 1). This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
A device history record review was performed for the subject device: part: 04. 211. 201s, lot: l295355, manufacturing site: (b)(4), release to warehouse date: 22. Feb. 2017, expiry date: 01. Feb. 2027. No ncrs were generated during production. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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 Name2.4/2.7MM TI VA LCKNG X-PLATE EXTRA SMALL-STERILE
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK RARON (CH)
kanalstrasse west 30
raron 3942
SZ 3942
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7289001
MDR Text Key100686377
Report Number8030965-2018-51307
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
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
Report Date 01/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.211.201S
Device Lot NumberL295355
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/22/2017
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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