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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH REAMER HEAD F/RIA 2 Ø13 ACCESSORIES, ARTHROSCOPIC

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SYNTHES GMBH REAMER HEAD F/RIA 2 Ø13 ACCESSORIES, ARTHROSCOPIC Back to Search Results
Catalog Number 03.404.022S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/02/2021
Event Type  Injury  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the reaming head came loose from the shaft and got stuck in the shaft. The patient was informed about the fragments remained in the body and the gamma nail was inserted. Procedure was completed successfully with sixty(60) minutes of surgical delay. This report is for one (1) reamer head f/ria 2 ø13. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
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 (b)(6) as follows: it was reported that on (b)(6) 2021, the reaming head came loose from the shaft and got stuck in the shaft. The patient was informed about the fragments remained in the body and the gamma nail was inserted. Procedure was completed successfully with sixty(60) minutes of surgical delay. This report is for one (1) reamer head f/ria 2 ø13. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
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.
 
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Brand NameREAMER HEAD F/RIA 2 Ø13
Type of DeviceACCESSORIES, ARTHROSCOPIC
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13056854
MDR Text Key286015092
Report Number8030965-2021-10387
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K111437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Notification
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.404.022S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-0577-2021

Patient Treatment Data
Date Received: 12/21/2021 Patient Sequence Number: 1
Treatment
DRIVE SHAFT F/RIA 2 L520; RIA 2 REAMING KIT L520
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