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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA A~¸10 LONG LE 130A^° L340 TAN; IMPACTOR
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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA A~¸10 LONG LE 130A^° L340 TAN; IMPACTOR Back to Search Results
Catalog Number 472.325S
Device Problem Break (1069)
Patient Problems Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Initial surgery: (b)(6) 2018.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4): the reported event required medical/surgical intervention to preclude permanent damage to a body structure and for nonunion, pain and medical device removal.A review of the device history record has been requested.The investigation could not be completed; 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that a fracture of pfna nail.Doi and dor unknown.Per the sales rep., the patient experienced pain with consecutive radiologic investigation, no infection.There were no issue observed during the revision surgery.The bone was not healed at the time of revision surgery.There were no x-rays available.Concomitant device reported: pfna blade (part# 04.027.035, lot# 50624, quantity# 1); locking bolt (part# 459.360, lot# 5943163, quantity# 1); unknown screw (part#459.303, lot# 594363, quantity# 1).This complaint involves one (1) device.This report is for one (1) pfna ø10 long le 130° l340 tan.This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
(b)(4).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.Patient initials: (b)(6).State: (b)(6).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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Awareness date reported on follow up 1 report as july 25, 2019 but should have been september 16, 2019.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, h4, h6: a review of the device history record device history lot, part# 472.325s, lot# l204415, manufacturing site: bettlach, release to warehouse date: 30.Nov.2016, expiry date: 01.Nov.2026.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: investigation summary investigation site: cq zuchwil, selected flow: damaged.Visual inspection: the received pfna nail is broken apart at the shaft near the slotted hole.Furthermore, there are several mechanical damages visible on the surface.Overall, the device is in a very used condition with discolorations and scratches all over.All features related to the reported complaint condition were reviewed and no other issues were identified.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 accordingly.Summary: the complaint condition is confirmed as the nail was found broken.The for the complaint relevant dimensions were checked as far as possible and found to be within specifications.This lot of 12 pieces was manufactured in november 2016, all devices are distributed and we are not aware of any other complaint for this part- and lot number combination.This and the findings above let us exclude a manufacturing related issue.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.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 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.
 
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Brand Name
PFNA A~¸10 LONG LE 130A^° L340 TAN
Type of Device
IMPACTOR
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8920690
MDR Text Key155201349
Report Number8030965-2019-67625
Device Sequence Number1
Product Code HWA
UDI-Device Identifier07611819291263
UDI-Public(01)07611819291263
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,Followup
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number472.325S
Device Lot NumberL204415
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2019
Date Manufacturer Received11/06/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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