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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH ROUTER QC 130MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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SYNTHES GMBH ROUTER QC 130MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 332.062
Device Problem Entrapment of Device (1212)
Patient Problems Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)
Event Date 10/10/2020
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.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
Device report from synthes reports an event in as follows: it was reported that on (b)(6) 2020, during an open reduction and internal fixation of a patient¿s distal humerus, one of the drill bits broke.The surgeon determined it would be too difficult to retrieve the piece and the tip was left it in place.Tip of broken drill bit remained in patient's bone.This report involves one router qc 130mm.This is report 1 of 1 for (b)(4).
 
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Brand Name
ROUTER QC 130MM
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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 Key15493582
MDR Text Key300666418
Report Number8030965-2022-07406
Device Sequence Number1
Product Code LXH
UDI-Device Identifier10886982192516
UDI-Public10886982192516
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
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? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number332.062
Device Catalogue Number332.062
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/07/2022
Initial Date FDA Received09/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age47 YR
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