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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER; SCREW, FIXATION, BONE

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SYNTHES GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER; SCREW, FIXATION, BONE Back to Search Results
Model Number 04.005.526S
Device Problem Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 01/20/2023
Event Type  Injury  
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.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.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.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 japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent the primary surgery with the tfna for the femoral trochanteric fracture.At the time of injury, it was p type, so that the elevator was used to change to type a.Then, it was fixed.At one week postoperatively, the patient was progressing well with the expected amount of sliding.Approximately three months after surgery on (b)(6) 2023, cut-out was confirmed under a type.Although blade insertion direction was slightly forward, the cause of cut-out is unknown.A revision surgery was scheduled to be performed.No further information is available.This report is for a 5.0mm ti locking screw w/t25 stardrive 36mm f/im nail-ster.This is report 3 of 4 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: g1: manufacture site updated.H3, h4, h6: 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 history lot part#04.005.526s lot # 8l82767 manufacturing site: früh verpackungstechnik ag supplier: werk selzach logistik release to warehouse date: 22 nov 2021 expiration date: 01 nov 2031 a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.-------- product code: 04.005.526 lot number: 493p631 manufacturing site: mezzovico release to warehouse date: 10 jan 2021 a manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.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
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK SELZACH
bohackerweg 5
selzach CO 2425
SZ   2425
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key16372064
MDR Text Key309492045
Report Number8030965-2023-01800
Device Sequence Number1
Product Code HWC
UDI-Device Identifier10886982085955
UDI-Public(01)10886982085955
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K000089
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number04.005.526S
Device Catalogue Number04.005.526S
Device Lot Number8L82767
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/23/2023
Initial Date FDA Received02/14/2023
Supplement Dates Manufacturer Received03/08/2023
Supplement Dates FDA Received03/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2021
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
TFNA END CAP EXTENS. 0 TAN; TFNA FEM NAIL Ø12 R 125° L235 TIMO15; TFNA HELICAL BLADE PERF L90 TAN
Patient Outcome(s) Required Intervention;
Patient Age90 YR
Patient SexFemale
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