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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - REAMERS: REAMER HEAD

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SYNTHES GMBH UNK - REAMERS: REAMER HEAD Back to Search Results
Catalog Number UNK - REAMERS: REAMER HEAD: TR
Device Problems Break (1069); Device-Device Incompatibility (2919)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/10/2020
Event Type  Injury  
Manufacturer Narrative

This report is for an unknown reamers: reamer head/unknown lot. Part and lot numbers are unknown; udi number is unknown. 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) 2020, during the procedure the reamer head broke. The fragment could not be removed from the femur due to the risk of complication. There was a twenty (20) minute surgical delay for guide repositioning. The procedure was completed successfully. There was no complication to the patient. This report involves one (1) reamers: reamer head. This is report 1 of 1 for (b)(4).

 
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Brand NameUNK - REAMERS: REAMER HEAD
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11141092
MDR Text Key225823543
Report Number8030965-2021-00196
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK - REAMERS: REAMER HEAD: TR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2021
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?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 01/08/2021 Patient Sequence Number: 1
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