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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/70MM; CERCLAGE, FIXATION
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SYNTHES GMBH 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/70MM; CERCLAGE, FIXATION Back to Search Results
Catalog Number 42.231.270
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Nonunion/Delayed-union Bone Fracture (2369); Malunion of Bone (4529)
Type of Reportable Event Serious Injury
Additional 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.B3: unknown when non-union occurred.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.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 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 or Problem Description
It was reported a revision surgery occurred (b)(6), 2024 due to a malunion/nonunion.Surgeon removed all implants that were currently in patient.Ria was used to collect bone graft and clean out the surgical site.Surgeon inserted new implants after restoring alignment and length.Original implant date unknown.It is not known how long the devices have been implanted for.This report is for one 5.0mm val screw/optilink(tm) slf-tpng/strdrv/70mm for (b)(4).
 
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Brand Name
5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/70MM
Common Device Name
CERCLAGE, FIXATION
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key19044073
Report Number8030965-2024-04558
Device Sequence Number8548371
Product Code JDQ
UDI-Device Identifier10886982259516
UDI-Public(01)10886982259516
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K162124
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2024
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Health Professional,Company Representative
Initial Reporter Occupation Physician
Type of Report Initial
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
Operator of Device Health Professional
Device Catalogue Number42.231.270
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/20/2024
Initial Report FDA Received Date04/04/2024
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Usage of Device Unknown
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
3.5 VA LCKNG SCR SLF-TPNG/SD/75; 3.5 VA LCKNG SCR SLF-TPNG/SD/75; 3.5 VA LCKNG SCR SLF-TPNG/SD/75; 5.0 VAL SCREOPTILINK(TM) SLF-TPNG/SD/70; 5.0 VAL SCREOPTILINK(TM) SLF-TPNG/SD/70; LCKNG ATTACH WASHER RFNA / 5 DEG/ LT/ S; LOCKING SCREW FOR IM NAIL 5/ 40/ XL25; LOCKING SCREW FOR IM NAIL 5/ 40/ XL25; RFNA/ 12MM/ 320MM/ STANDARD BEND/ STER
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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