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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II Ø10 XS 125° L170 TAN ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH PFNA-II Ø10 XS 125° L170 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 472.101S
Device Problem Migration (4003)
Patient Problems Bone Fracture(s) (1870); Pain (1994)
Event Date 01/01/2022
Event Type  Injury  
Manufacturer Narrative
Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation. Initial reporter occupation: reporter is a j&j sales representative. Device is not distributed in the united states, but is similar to device marketed in the usa. Device evaluated by mfr and manufacture date: a device history record (dhr) review was conducted: part # 472. 101s, lot # 64p5091, manufacturing site: (b)(4), release to warehouse date: (b)(6) 2020, expiry date: 01. August. 2030, a manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified. Device evaluated by mfr: the investigation could not be completed; no conclusion could be drawn, as no product was received. 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 depuy synthes reports an event in japan as follows: it was reported that on (b)(6) 2021, the patient underwent a surgery with the proximal femoral nail anti-rotation (pfna) system. The surgery was completed successfully without any surgical delay. The patient had been doing well since the surgery; however, patient fell down on (b)(6) 2022. The patient went to the hospital and complained of pain on (b)(6) 2022. It was confirmed that proximal cut-out and a secondary fracture at the distal nail occurred. The revision surgery was performed on (b)(6) 2022. No further information is available. This report is for one (1) pfna-ii ø10 xs 125° l170 tan. This is report 2 of 2 for complaint (b)(4).
 
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Brand NamePFNA-II Ø10 XS 125° L170 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
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
kate karberg
1302 wrights lane east
west chester, PA 19380
8472871282
MDR Report Key14630035
MDR Text Key293527500
Report Number8030965-2022-03761
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819837263
UDI-Public(01)07611819837263
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number472.101S
Device Lot Number64P5091
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2020
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/08/2022 Patient Sequence Number: 1
Treatment
PFNA-II BLADE L80 TAN
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