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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 13.0MM REAMER HEAD FOR RIA 2 STERILE

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SYNTHES GMBH 13.0MM REAMER HEAD FOR RIA 2 STERILE Back to Search Results
Catalog Number 03.404.022S
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2023
Event Type  malfunction  
Event Description
Device report from synthes reports an event in the united kingdom as follows: it was reported that during surgery on (b)(6) 2023, when the surgeon tried to pull the ria out from the canal, it was noticed that the reamer head had come detached.This was successfully removed using the olive tip wire.However, four small metal splinters were present in the bone canal on the x-ray.They were successfully removed using suction, and a new reamer head was used to complete the procedure.No other medical intervention was required.Upon inspection, the spikes where the reamer head attaches to the metal drive shaft had become broken.This report is for a 13.0mm reamer head for ria 2 sterile.This is report 1 of 1 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.H10 additional narrative: d2b: additional device product codes: hrx.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.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.
 
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Brand Name
13.0MM REAMER HEAD FOR RIA 2 STERILE
Type of Device
REAMER
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 Key16902008
MDR Text Key314900897
Report Number8030965-2023-05989
Device Sequence Number1
Product Code HTO
UDI-Device Identifier07612334142443
UDI-Public(01)07612334142443
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K111437
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 Number03.404.022S
Device Lot Number3181P22
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/26/2023
Initial Date FDA Received05/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2022
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
UNK - RIA: DRIVE SHAFT.
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