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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: PFNA BLADE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: PFNA BLADE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number UNK - NAIL HEAD ELEMENTS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Non-union Bone Fracture (2369)
Event Type  Injury  
Event Description
Device report from depuy synthes reports an event in (b)(6) as follows: this is report 2 of 4 for (b)(4). It was reported that on april 1, the patient underwent the open reduction internal fixation with the pfna for the fracture of the trochanteric femur on unknown date. It was reported that the surgery was completed successfully without any surgical delay. However, after the surgery, pseudoarthrosis had occurred. It was reported that the revision surgery with removal of the pfna and the bipolar hip arthroplasty was performed on (b)(6) 2022. According to the surgeon, the patient had a medical history of acth deficiency and diabetes mellitus and was taking steroids. It was reported that the use of steroids might have made it difficult to achieve bone healing that might cause pseudoarthrosis. This event was not due to the implants malfunction. No further information is available. This report is for one (1) unk - nail head elements: pfna blade device. This complaint involves four (4) devices.
 
Manufacturer Narrative
This report is for an unknown device/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j employee. 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. 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. 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 NameUNK - NAIL HEAD ELEMENTS: PFNA BLADE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14223299
MDR Text Key290270035
Report Number8030965-2022-02752
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK - NAIL HEAD ELEMENTS
Was Device Available for Evaluation? No
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/27/2022 Patient Sequence Number: 1
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