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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 1303 GOSHEN SYNTHES USA PRODUCTS LLC UNK - PLATES: FNS PLATE, FIXATION, BONE

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1303 GOSHEN SYNTHES USA PRODUCTS LLC UNK - PLATES: FNS PLATE, FIXATION, BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/04/2021
Event Type  Injury  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that, the patient underwent surgery of left femur with fna implants at another hospital. The revision surgery was performed on (b)(6) 2021, for the removal of the fna implants. The surgeon tried to remove the locking screw and plate by cutting the head of the locking screw with a carbide drill. The plate was stuck to the bone firmly, and it remained in the body. A bolt and anti-rotation screw were removed. Procedure was completed successfully without any surgical delay. The patient's younger age of (b)(6) is assumed to be the primary cause of the event. Concomitant device reported: unk: nail head elements: fns antirotation. Unk: nail head elements: fns bolt. Unk: carbide drill. This report is for one (1) unk: plates: fns. This is report 2 of 2 for complaint.
 
Manufacturer Narrative
This report is for an unk - plates: fns/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. Initial reporter occupation: reporter is a j&j employee. (b)(4). 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 NameUNK - PLATES: FNS
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
1303 GOSHEN SYNTHES USA PRODUCTS LLC
1303 goshen parkway
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12925423
MDR Text Key286646704
Report Number2530088-2021-00027
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/03/2021 Patient Sequence Number: 1
Treatment
UNK - CARBRIDE DRILL; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - NAIL HEAD ELEMENTS: FNS BOLT; UNK - SCREWS: FNS LOCKING
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