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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STER ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH 8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STER ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.016.035S
Device Problems Use of Device Problem (1670); Failure to Align (2522)
Patient Problem No Code Available (3191)
Event Date 07/23/2019
Event Type  Injury  
Manufacturer Narrative
Additional pro-code: hsb. Expiration date and lot number unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number, the device history records review could not be completed as no product was received. Investigation summary product was not returned. Based on the information available, it has been determined that no corrective and 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 (b)(6) 2019, the surgeon underwent open reduction internal fixation surgery for proximal humerus epiphyseal fracture with the multiloc proximal humeral nail and the locking screw. After implanting all devices, the surgeon checked by x-rays and found that the screw in the most distal hole was displaced. The surgeon removed the screw. The surgeon considered that it is dangerous to insert the screw again because it may cause secondary fracture, and he didn't insert screw in the hole. Only one (1) locking screw was inserted in distal locking. The surgery was delayed by less than 30 minutes. No further information is available. Concomitant device reported: titanium multiloc proximal humeral nail (part # 04. 016. 035s, lot # unknown, quantity 1 and unknown screws (part # unknown, lot # unknown, quantity unknown). This complaint involves one (1) device. This complaint is 2 of 2 for (b)(4).
 
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Brand Name8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STER
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8907775
MDR Text Key154938845
Report Number8030965-2019-67463
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,Followup
Report Date 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.016.035S
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 Received08/22/2019
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

Patient Treatment Data
Date Received: 08/19/2019 Patient Sequence Number: 1
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