• 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 10MM/125 DEG TI CANN TFNA 300MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

  • 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 10MM/125 DEG TI CANN TFNA 300MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.020S
Device Problem Break (1069)
Patient Problem Non-union Bone Fracture (2369)
Event Type  Injury  
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 the osteosynthesis surgery for pathological subtrochanteric fracture of femur with trochanteric fixation nail-advanced (tfna) implants.The surgery was completed successfully.Four and a half months after the surgery, the tfna nail was broken, and the revision surgery was performed via bha surgery on (b)(6) 2021.The surgeon commented that stress concentrated on the nail and the nail was broken due to metal fatigue, because the fracture was pathological fracture and bone union could not be obtained.The patient also received radiotherapy for bone metastases originating from breast cancer in other sites.No further information is available.This report is for one (1) 10mm/125 deg ti cann tfna 300mm/right - sterile.This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.
 
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: part #04.037.020s, synthes lot #26p9453, supplier lot # n/a, release to warehouse date: november 15, 2019, manufactured by:werk selzac.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned tfna fem nail ø10 r 125° l300 timo15 determined that the nail had broken across the proximal helical blade junction hole.Signs of use could be noted on the device which would not contribute to the complaint condition.No other issues were identified.The dimensional inspection was performed and the device met specifications.The observed condition of the tfna fem nail ø10 r 125° l300 timo15 was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the tfna fem nail ø10 r 125° l300 timo15 was observed to have broken postoperatively.While no definitive root cause could be determined from the available information, it is probable that the tfna fem nail ø10 r 125° l300 timo15 had broken due to exposure to excessive/unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed? the following drawings reflecting the current and manufactured revisions were reviewed: - ti cannulated trochanteric fixation nail - advanced, 125 deg - ø10mm ti cannulated trochanteric femoral nail - right.Dimensional inspection: major outer diameter: conforming device used: caliper.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.D9, h3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
10MM/125 DEG TI CANN TFNA 300MM/RIGHT - STERILE
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach CO 2545
SZ   2545
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13261412
MDR Text Key287907613
Report Number8030965-2022-00359
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819649743
UDI-Public(01)07611819649743
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
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? Yes
Device Operator Health Professional
Device Catalogue Number04.037.020S
Device Lot Number26P9453
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/21/2021
Initial Date FDA Received01/14/2022
Supplement Dates Manufacturer Received01/17/2022
03/14/2022
Supplement Dates FDA Received02/14/2022
03/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2019
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN; TFNA HELICAL BLADE PERF L75 TAN
Patient Outcome(s) Required Intervention;
Patient Age82 YR
Patient SexFemale
Patient Weight48 KG
-
-