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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PHN MULTILOC Ø8 DCHO CAN L160 TAN ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PHN MULTILOC Ø8 DCHO CAN L160 TAN ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.016.034S
Device Problem Off-Label Use (1494)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. 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. 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 an unknown date, the multiloc proximal humeral nail for right was delivered to the hospital. The hospital originally wanted the multiloc proximal humeral nail for left, but the sales rep made typo. When the implant was delivered, the hospital wasn't aware of the mistake. On (b)(6) 2019, the patient underwent open reduction internal fixation surgery for left proximal humerus fracture with the humeral nail for right. After the patient was under anesthesia, the surgeon was aware of the mistake, but the surgeon implanted the humeral nail for right without any change, and the surgery was completed successfully. The surgical delay is unknown. No further information is available. Concomitant devices reported: unknown locking screws (part#unknown, lot#unknown, quantity unknown). This is 1 of 1 for report (b)(4).
 
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Brand NamePHN MULTILOC Ø8 DCHO CAN L160 TAN
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
6107195000
MDR Report Key9330114
MDR Text Key182988788
Report Number8030965-2019-70294
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.016.034S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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