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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH LOCKING Y-PLATE 1.3 HE 3HO SHAFT 5HO L27; PLATE, FIXATION, BONE

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SYNTHES GMBH LOCKING Y-PLATE 1.3 HE 3HO SHAFT 5HO L27; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.130.153S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2024
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.D2b: additional product code: hwc.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j sales representative.H3, h6: 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 synthes reports an event in japan as follows: it was reported that on (b)(6) 2024, the patient underwent an orif for fifth metacarpal diaphyseal fracture.The locking screw was inserted but unlocked in a hole in the y-shaped plate.And then, the locking screw in question was tried to be inserted to another hole, and unlocked situation remained.Meanwhile, the unfitting hole was reattempted to be inserted by other screw, and locking was successful.The surgeon commented that the cause for the unlocked situation is likely the screw in question itself.The surgery was completed successfully without any surgical delay.Patient status, stable.No further information is available.2 items has been registered as impacted products for the screws.This is because it is unclear which lot of screws is the actual complaint item.The surgery was completed without any problems with implant fixation due to the use of an alternative.This report is for one (1) locking y-plate 1.3 he 3ho shaft 5ho l27.This is report 3 of 4 for (b)(4).
 
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Brand Name
LOCKING Y-PLATE 1.3 HE 3HO SHAFT 5HO L27
Type of Device
PLATE, FIXATION, BONE
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 Key18596323
MDR Text Key333972339
Report Number8030965-2024-01471
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07611819692015
UDI-Public(01)07611819692015
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K150099
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
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 Number04.130.153S
Device Lot Number224P248
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/11/2024
Initial Date FDA Received01/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/02/2021
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
CORTSCR ø1.3 SELF-TAP L9 TAN; LOCKSCR ø1.3 SELF-TAP L9 TAN; LOCKSCR ø1.3 SELF-TAP L9 TAN
Patient SexFemale
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