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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAILS-STER ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAILS-STER ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.005.428S
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/22/2018
Event Type  malfunction  
Manufacturer Narrative
Device used for treatment, not diagnosis. Patient information not available for reporting. Additional product code: hwc. Device is an instrument and is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. Investigation summary: reviewing dhr shows that the affected lot was released after complete final inspection with no detected issues regarding manufacturing procedure. This screw was released in faultless condition. For details, please see appropriate section device history. Based on the complaint description, without material we are not able to perform any investigation. Device history lot: please note, this dhr review is for sterilization procedure only: part no. : 04. 005. 428s. Lot no. : 8670708. (b)(4). Supplier: (b)(4). Release to warehouse date: 20. Oct. 2013. Expiry date: 01. Oct. 2023. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Non-sterile 04. 005. 428/8623882 was manufactured in (b)(4). Release to warehouse date: 17. Sep. 2013. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Product was not returned. 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.
 
Event Description
Device report from synthes on an event in (b)(6) as follows: it was reported that the orif was applied to proximal humeral fractures on (b)(6) 2018. While the surgeon was inserting locking screw in question into a multiloc humeral nail, it was found that there were metal fragments around the locking screw. The metal fragments were same color as the locking screw. Because it was not specified where the fragments came from, the surgeon stopped using the locking screw in question, cleaned the screw hole area, closed the incision, and completed the rest of the surgery within a 30-minute delay. The patient has been in stable condition since the surgery. This complaint involves one part. This report is 1 of 1 for (b)(4).
 
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Brand Name4.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAILS-STER
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 Key7430344
MDR Text Key105545344
Report Number8030965-2018-53102
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 03/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.005.428S
Device Lot Number8670708
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 Received03/22/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/20/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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