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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: TIBIAL; NAIL, FIXATION, BONE

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SYNTHES GMBH UNK - NAILS: TIBIAL; NAIL, FIXATION, BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2024
Event Type  malfunction  
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.D1, d2, d3, d4, g5 ¿ 510k: this report is for an unk - nails: tibial/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.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 Description
It was reported that on mar 11, 2024, the tna aiming arm proximal medial to lateral interlocking screws missing the nail.There was no delay due to the reported event.There were no patient consequences/outcome.This report is for one (1) unk - nails: tibial this is report 2 of 2 for complaint (b)(4).
 
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Brand Name
UNK - NAILS: TIBIAL
Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key18978576
MDR Text Key338597825
Report Number8030965-2024-04093
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
0
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2024
Initial Date FDA Received03/26/2024
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
AIMING ARM/ RADIOLUCENT; UNK - SCREWS: NAIL LOCKING
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