• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PFNA 10 130 L240 TAN ROD, FIXATION, INTRAMEDULLARY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES GMBH PFNA 10 130 L240 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 472.265S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/22/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received. Reporter is a j&j sales representative. The investigation could not be completed, no conclusion could be drawn at the time of filing this report. Investigation summary: the breakage of the nail could be confirmed according to the received pictures. 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. 265s, lot: 81p0163. Manufacturing site: (b)(4), release to warehouse date: december 22, 2020, expiry date: december 01, 2030. A manufacturing record evaluation was performed for the finished device lot number, and no non conformance 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 revision surgery due to broken pfna nail. The pfna nail was implanted on unknown date of (b)(6) 2021 and broke on the (b)(6) 2021. The bottom part of the broken nail could not be removed during revision and remained in the patient. It was unknown if the revision surgery completed successfully. The patient outcome was unknown. Concomitant device reported: pfna blade perf l105 tan (part # 04. 027. 036s; lot # 79p9536; quantity: 1). Lockscr ø5 l36 f/nails tan light green (part # 04. 005. 526; lot # 54p0445; quantity: 1). This complaint involves one (1) device. This report is for (1) unk - plates. This report is 1 of 1 (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePFNA 10 130 L240 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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11689184
MDR Text Key247025870
Report Number8030965-2021-03040
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number472.265S
Device Lot Number81P0163
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 Received05/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/19/2021 Patient Sequence Number: 1
-
-