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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE; PLATE,FIXATION,BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE; PLATE,FIXATION,BONE Back to Search Results
Catalog Number 04.210.118TS
Device Problem Unintended Movement (3026)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Additional product code hwc.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient was treated for a secondary disassociated distal radius extension fracture due to fracture wasn't fixated as planned.It is unknown how the issue was discovered.It is unknown if there was a patient consequence.This complaint involves ten (10) devices.This report is for (1) 2.4mm ti va locking screw stardrive 18mm sterile.This is report 3 of 10 for (b)(4).Related product complaint: (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6 investigation summary 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 history part number: 04.210.118ts, lot number: 6l88136, manufacturing site: selzach, supplier: (b)(4) , release to warehouse date: 30.Apr.2020, expiry date: 01.Apr.2025.Device was first manufactured unsterile under the lot 47p3484 in the us and sterilized afterwards.As this complaint is neither packaging nor sterilization related only the manufacturing documents of the unsterile device 04.210.118 with lot 47p3484 need to be reviewed: part number: 04.210.118, 2.4mm ti va locking screw stardrive 18mm, lot number: 47p3484 (non-sterile), manufacturing location: monument, release to warehouse date: 16-mar-2020, lot quantity: 239.One piece was scrapped in cell at op #70, flow inspect/pack, after being dropped.Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, mill shaft thread / head thread / flute, met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during inspection or release that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿two column plate radius cannot be fixated properly¿ does not indicate breakage.Therefore, review of the raw material would not be pertinent to the reported 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.
 
Event Description
Update: the initial surgery occurred (b)(6) 2020.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.B4: alert date should be 8/13/2020, not 9/14/2020.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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
Update: no additional revision surgery was performed due to the event.
 
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Brand Name
2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE
Type of Device
PLATE,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10582047
MDR Text Key208548739
Report Number8030965-2020-07372
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07612334104120
UDI-Public(01)07612334104120
Combination Product (y/n)N
PMA/PMN Number
K103243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.210.118TS
Device Lot Number6L88136
Was Device Available for Evaluation? No
Date Manufacturer Received10/27/2020
Patient Sequence Number1
Treatment
CORTSCR Ø2.4 SELF-TAP L14 TAN; CORTSCR Ø2.4 SELF-TAP L16 TAN; VA LOCKSCR Ø2.4 SELF-TAP L12 TAN; VA LOCKSCR Ø2.4 SELF-TAP L14 TAN; VA LOCKSCR Ø2.4 SELF-TAP L16 TAN; VA-LCP-2-COLUMN DRP2.4 VOLAR LE SHAFT 3H
Patient Outcome(s) Required Intervention;
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