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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1FNA Ø10 LONG LE 130° L340 TAN; ROD, FIXATION, BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH 1FNA Ø10 LONG LE 130° L340 TAN; ROD, FIXATION, BONE Back to Search Results
Catalog Number 472.325S
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Date of event reported as 2018, exact date is not known.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.Without a lot number the device history records review could not be completed.Product was not returned.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 europe reports an event in (b)(6) as follows: it was reported that patient was implanted with a proximal femoral nail antirotation (pfna) nail and two (2) bolts on (b)(6) 2018.On unknown date it was revealed that the nail and two (2) bolts were broken.This report is for one (1) pfna nail.This is report 1 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional information provided.Part: 472.325s; lot: l411556; manufacturing site: bettlach; release to warehouse date: may 19, 2017; expiry date: may 01, 2027.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.The returned broken pfna nail was forwarded to the manufacturing site for evaluation.The statement below is a summary of their investigation.The outer (10 mm) and inner diameter (4.4 mm) were measured and have fulfilled the specifications.Besides, during the manufacturing process these features were inspected through the inspection sheet and the whole lot has passed its specifications.Therefore, the nail was manufactured according to its quality standards and a manufacturing issue can be excluded.For implants, there is no hardness test required/defined.The raw material certificate was checked, and the used raw material has fulfilled the specifications.Based on the investigation result, this complaint is rated as confirmed since the nail is broken as claimed by the customer.However, from the manufacturing point of view, the relevant features were measured and have fulfilled its specifications as well as in the manufacturing documentation, no issue was identified.Due to no manufacturing issue was identified and this complaint is not valid, no additional actions are required.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 the design and clinical risk management (dcrm) document was reviewed and found to adequately address the harm of this complaint condition.Code 3191 used to capture required surgical intervention and device removal.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
There were fragments generated from the broken devices.Procedure was completed successfully with no delay.Patient outcome was unknown.Concomitant devices: pfna helical blade (part: 04.027.038s, lot: unknown, quantity: 1).
 
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.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.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
Reportedly the patient was implanted with a hip prosthesis (proximal femur replacement).Updated concomitant device: pfna blade (part 04.027.038s, lot l21xxxx, quantity 1).
 
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Brand Name
1FNA Ø10 LONG LE 130° L340 TAN
Type of Device
ROD, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8141582
MDR Text Key129593810
Report Number8030965-2018-58821
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819293168
UDI-Public(01)07611819293168
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 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number472.325S
Device Lot NumberL411556
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Date Manufacturer Received02/01/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient Weight76
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