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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VA LOCKSCR A~¸2.7 HEAD 2.4 SELF-TAP L18 SS; SCREW, FIXATION, VONE
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OBERDORF SYNTHES PRODUKTIONS GMBH VA LOCKSCR A~¸2.7 HEAD 2.4 SELF-TAP L18 SS; SCREW, FIXATION, VONE Back to Search Results
Catalog Number 02.211.018S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Patient Involvement (2645)
Event Date 12/19/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).This report is for an unknown screws: locking/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.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 as no product was received.If lot number is: 6l26755, then a review of the device history record will be requested.If part #02.221.018: device is not distributed in the united states, but is similar to device marketed in the usa.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventive 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 at bedford 02.118.402s (va-lcp lateral distal fibula plate lot- 3l43793) was used on a patient.Unfortunately the va locking screws 02.221.018s (lot- 3l83306 and lot- 6l26755) we¿re spinning inside the locking hole of the plate.The surgeons couldn¿t lock it.The plate and screws were left in the patient as per surgeons decision.Unk screw: part number(s) (device name if part number unknown): 02.221.018s, lot/serial number(s): (b)(4).This complaint involves three (3) devices.This report is 3 of 3 for (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.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.H3, h4, h6: sterile part: part: 02.211.018s, lot: 6l26755, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 30.Sep.2019, expiry date: 01.Sep.2029.Since there is no allegation against packing or sterility, a manufacturing record evaluation was not performed.Non-sterile part: part: 02.211.018, lot: 12l3525, manufacturing site: synthes usa hq, inc.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 united kingdom reports an event as follows.
 
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Brand Name
VA LOCKSCR A~¸2.7 HEAD 2.4 SELF-TAP L18 SS
Type of Device
SCREW, FIXATION, VONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9583618
MDR Text Key190646429
Report Number8030965-2020-00337
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02.211.018S
Device Lot Number6L26755
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/19/2019
Initial Date FDA Received01/13/2020
Supplement Dates Manufacturer Received01/10/2020
01/22/2020
Supplement Dates FDA Received01/16/2020
02/11/2020
Patient Sequence Number1
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