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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH DRIVE SHAFT FOR RIA 2 520MM ACCESSORIES, ARTHROSCOPIC

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SYNTHES GMBH DRIVE SHAFT FOR RIA 2 520MM ACCESSORIES, ARTHROSCOPIC Back to Search Results
Catalog Number 03.404.035
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/07/2021
Event Type  Injury  
Manufacturer Narrative
Additional procode: hto. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a j&j employee. 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 during the procedure, the drive shaft for ria 2 broke when drilling with the smaller head. Fragments were generated from the flaps used to clip the drilling heads. Fragments remained in the patient's femoral shaft. There was a surgical delay of (30) minutes. This report is for (1) drive shaft for ria 2 520mm. This is report 1 of 1 for (b)(4).
 
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Brand NameDRIVE SHAFT FOR RIA 2 520MM
Type of DeviceACCESSORIES, ARTHROSCOPIC
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12453456
MDR Text Key270820979
Report Number8030965-2021-07633
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K111437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.404.035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/10/2021 Patient Sequence Number: 1
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