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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 80MM; ROD,FIXATION,INTRAMEDULLARY
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OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 80MM; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.038.280S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 in (b)(6) 2017, the patient underwent the surgery by using a competitors femoral implant system in order to prevent bone fractures due to the breast cancer being spread to the femur.On (b)(6) 2020, a revision surgery was performed to replace the femoral implants due to device breakage with synthes trochanteric fixation nail antirotation (tfna) long implants.On (b)(6) 2020, a revision surgery was performed due to the breakage of the tfna long implants.The patient was revised to another set of implants.There was a one (1) hour surgical delay due to extended time in removing the broken device.It was further reported the patient also had a non-union which may have contributed to the device breakage.This is report 5 of 5 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: customer quality (cq) zuchwil selected flow: adverse event (no reported product problem).Visual inspection: the visual inspection has shown that the device is in a used condition, there are different wear marks visible.At all visible damages is the anodized layer worn away, which indicates that they were caused post-manufacturing.Investigation conclusion: the helical blade was returned as a concomitant device without an alleged complaint condition.Upon visual inspection, there is no evidence that this device contributed to the complaint condition, neither the breakage not the non-union.The visible wear marks can be traced back to the insertion, the time in-situ and extraction.There is no indication that they had any influence on the functionality of the device and therefore the complaint is rated as unconfirmed for this device.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: manufacturing location: elmira / packaged, sterilized and released by: monument release to warehouse date: september 24, 2019, expiration date: september 1, 2029, part number: 04.038.280s, tfna helical blade 80mm -sterile, lot number: 17p2464 (sterile).Note: helical blade was manufactured by elmira; lot number 15l7038.Parts were packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) lmd rev ac was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 16667 supplied by sterigenics was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history review: july 14, 2020: dhr reviewed by: mschoenfeld this lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.H4 device history part number: 04.038.280, lot number: 15l7038, part manufacture date: 05-sep-2019, manufacturing location: elmira, part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 80mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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
TFNA HELICAL BLADE 80MM
Type of Device
ROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10343668
MDR Text Key201062258
Report Number8030965-2020-05435
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982098955
UDI-Public(01)10886982098955
Combination Product (y/n)N
PMA/PMN Number
K131548
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 07/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number04.038.280S
Device Catalogue Number04.038.280
Device Lot Number15L7038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2020
Initial Date Manufacturer Received 07/09/2020
Initial Date FDA Received07/30/2020
Supplement Dates Manufacturer Received08/11/2020
09/17/2020
Supplement Dates FDA Received09/03/2020
09/17/2020
Patient Sequence Number1
Treatment
LOCKSCR Ø5 L42 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L48 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN; TFNA FEM NAIL Ø12 LE 125° L340 TIMO15; LOCKSCR Ø5 L42 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L48 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN; TFNA FEM NAIL Ø12 LE 125° L340 TIMO15
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient Weight52
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