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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II BLADE L85 TAN ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH PFNA-II BLADE L85 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.052S
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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. Initial reporter is j&j company representative. Device is not distributed in the united states, but is similar to device marketed in the usa. The investigation could not be completed. No conclusion could be drawn, as no product was received. A review of the device history records has been requested. 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 europe reports an event in (b)(6) as follows: it was reported that the 04. 027. 052 pfna ii blade got damaged while inserting the blade into the nail on table. Surgery was delayed 10 minutes due to the reported event. Procedure was successfully completed. Concomitant device reported: unknown nail (part# unknown, lot# unknown, quantity 1). This complaint involves one (1) device. This report is for one (1) pfna-ii blade l85 tan. This report is for 1 of 1 for (b)(4).
 
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Brand NamePFNA-II BLADE L85 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
kara ditty-bovard
1302 wrights lane east
west chester, PA 
MDR Report Key11778947
MDR Text Key250074668
Report Number8030965-2021-03580
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.052S
Device Lot Number57P1262
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown

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