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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II Ø11 SM 130° L200 TAN NAIL, FIXATION, BONE

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SYNTHES GMBH PFNA-II Ø11 SM 130° L200 TAN NAIL, FIXATION, BONE Back to Search Results
Catalog Number 472.116S
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Note: description updated to remove dr. Brian coutiho & "kindly note the complaint is raised late since i had a family medical emergency from (b)(6). " the investigation could not be completed, no conclusion could be drawn at the time of filing this report. 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 history lot: part: 472. 116s, lot: 68p6342, manufacturing site: (b)(4). Release to warehouse date: september 28, 2020. Release to warehouse date: september 01, 2030. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. 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, the patient underwent for a fracture nailing surgery. During the surgery, while inserting the blade through the nail, the blade wasn't going through. He was unable to insert the nail. The surgery was delayed five minutes. The surgery was completed successfully. There were no patient consequences are reported. Concomitant device reported: unknown pfna ii blade (part# unknown; lot# unknown; quantity: 1). This complaint involves one (1) device. This report is for (1) pfna-ii ø11 sm 130° l200 tan. This report is 1 of 1 (b)(4).
 
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Brand NamePFNA-II Ø11 SM 130° L200 TAN
Type of DeviceNAIL, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11720371
MDR Text Key249798180
Report Number8030965-2021-03239
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/29/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received04/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number472.116S
Device Lot Number68P6342
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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