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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 26MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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SYNTHES GMBH 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 26MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Back to Search Results
Model Number 212.109
Device Problem Material Deformation (2976)
Patient Problems Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/29/2022
Event Type  Injury  
Event Description
Device report from synthes reports an event in france as follows: it was reported on (b)(6) 2022 there was lack of locking of 2.7 mm locking screws in two (2) low compression plate (lcp) elbow plates with a dynamometric screwdriver intraoperatively.Several screws bent and there were two (2) edges on one side.The patient was immobilized for ten (10) days and x-rays were taken.A surgical revision is planned to remove everything but has not yet been completed.Implants are still currently implanted in the patient.This is report 3 of 12 for (b)(4).This report is for a locking screw.
 
Manufacturer Narrative
Additional narrative: devices were not explanted but a revision is expected.Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Code not available is for injury/revision surgery needed 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5: subsequent follow-up with the customer, additional information was received regarding the event.It was reported that there was unlocking of the screw relative to the plate and retraction of the screws.It was reported that the customer encountered an incident with the 2 lcp plates.It was reported that the implant had been in the patient for 10 days.It was reported that there was a cast immobilization.
 
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: d4.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: part: 0212.109ts, lot#: 117p850, manufacturing site: mezzovico, release to warehouse date: 25 jun 2021, a manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.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.H6: health effect - clinical code.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.
 
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Brand Name
3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 26MM
Type of Device
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ   2545
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14949914
MDR Text Key295472776
Report Number8030965-2022-04637
Device Sequence Number1
Product Code KTT
UDI-Device Identifier10886982151834
UDI-Public(01)10886982151834
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number212.109
Device Catalogue Number212.109TS
Device Lot Number117P850
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
LOCKSCR ø3.5 SELF-TAP L22 SST; LOCKSCR ø3.5 SELF-TAP L22 SST; VA LOCKING SCREW STARDRIVE; VA LOCKING SCREW STARDRIVE® ÿ 2.7 MM (HE; VA LOCKING SCREW STARDRIVE® ÿ 2.7 MM (HE; VA LOCKING SCREW STARDRIVE® ÿ 2.7 MM (HE; VA LOCKING SCREW STARDRIVE® ÿ 2.7 MM (HE; VA LOCKING SCREW STARDRIVE® ÿ 2.7 MM (HE; VA LOCKING SCREW STARDRIVE® ÿ 2.7 MM (HE; VA-LCP DHP 2.7/3.5 LAT LE MED 2HO L82 SS; VA-LCP DHP 2.7/3.5 MED LE LONG 4HO L108
Patient Outcome(s) Required Intervention;
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