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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH EXPERT A2FN NAIL Ø9 R CANN L360 TAN LIGH FEMUR NAIL, STERILE

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SYNTHES GMBH EXPERT A2FN NAIL Ø9 R CANN L360 TAN LIGH FEMUR NAIL, STERILE Back to Search Results
Catalog Number 04.009.252S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/28/2022
Event Type  Injury  
Event Description
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported by the customer in (b)(6) that postoperatively to an unknown surgery of the femur on (b)(6) 2022, a patient underwent a removal of femoral nail device to prepare for the total knee replacement in the future. The date of the aforementioned was not provided. The status of the patient was unknown. No additional information was provided. This report is for one (1) expert a2fn nail ø9 r cann l360 tan ligh device. This complaint involves 1 device.
 
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. The lot number was unknown. Therefore, the expiration date and device manufacture date were unknown. Without a lot number the device history records review could not be completed. (b)(4). Investigation summary: product was not returned. Based on the information available, it has been determined that no corrective and 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.
 
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Brand NameEXPERT A2FN NAIL Ø9 R CANN L360 TAN LIGH
Type of DeviceFEMUR NAIL, STERILE
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 Key14193265
MDR Text Key289972134
Report Number8030965-2022-02668
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K040336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,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
Date FDA Received04/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.009.252S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2022
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 Unkown

Patient Treatment Data
Date Received: 04/25/2022 Patient Sequence Number: 1
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