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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PFNA 10 125 L240 TAN; ROD, FIXATION, INTRAMEDULLARY
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SYNTHES GMBH PFNA 10 125 L240 TAN; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 472.260S
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Event occurred on an unknown date in 2020.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.(b)(4).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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the pfna nail broke and caused the patient to experience pain.The patient underwent revision surgery on (b)(6) 2020 to have the broken nail removed.The surgeon placed a new nail in the patient.There is no further information available.Concomitant devices reported: unknown nail head elements: pfna blade (part# unknown, lot# unknown, quantity# 1).Unknown screws: locking (part# unknown, lot# unknown, quantity# 1).This report is for one (1) pfna ø10 125° l240 tan.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation summary investigation site: cq zuchwil, selected flow: damaged: visual | examples: deformed/bent/cracked/broken.Visual inspection: the investigation of the returned pfna nail has shown that the nail is broken off through the distal locking hole.Furthermore, the thread is damaged and several scratches and discoloration are visible all over the device.In general, the device is in a very used condition.Dimensional inspection: feature: outer diameter head, drawing:, caliper: 3-01-20766.Dimension drawing: dimension measured: result: pass.Feature: outer diameter shaft drawing: caliper: 3-01-20766.Dimension drawing: dimension measured: result: pass.Feature: inner diameter drawing: caliper: 3-01-20766 dimension drawing: dimension measured: result: pass.Drawing/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Furthermore, as indicated in the manufacturing documents, the correct material (tan/ti6al7nb) was used according iso 5832-11.Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed as the nail was found broken.The dimensions relevant to this complaint were checked as well as possible and found to be within specifications.The review of the production history revealed that these instruments were manufactured in november 2019 according to the specifications.No manufacturing related issues that would have contributed to this complaint were found.We conclude that the cause of failure is not due to any manufacturing non-conformances.Based on the provided information we are not able to determine the exact cause of this breakage.We can only assume that any occurrence during the healing process, e.G.Non-union, delayed union, mal union, overloading of the osteosynthesis or a combination of different factors, did lead to a fatigue failure.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected device history lot part: 472.260s, lot: 22p9223, manufacturing site: bettlach, release to warehouse date: nov 11, 2019, expiry date: nov 1, 2029.A manufacturing record evaluation was performed for the finished device 472.260s lot: 22p9223 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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
Updated event description concomitant devices reported: pfna blade perf l105 tan (part# 04.027.036s, lot# 29p7152, quantity# 1) , lockscr ø5 l48 f/nails tan light green (part# 04.005.538, lot# l857090, quantity# 1).
 
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Brand Name
PFNA 10 125 L240 TAN
Type of Device
ROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10840234
MDR Text Key217961724
Report Number8030965-2020-08937
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819291034
UDI-Public(01)07611819291034
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number472.260S
Device Lot Number22P9223
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2020
Date Manufacturer Received12/15/2020
Patient Sequence Number1
Treatment
LOCKSCR Ø5 L48 F/NAILS TAN LIGHT GREEN; PFNA BLADE PERF L105 TAN; UNK - NAIL HEAD ELEMENTS: PFNA BLADE; UNK - SCREWS: LOCKING
Patient Outcome(s) Required Intervention;
Patient Age86 YR
Patient Weight74
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