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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA SCREW 115MM - STERILE; ROD,FIXATION,INTRAMEDULLARY
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SYNTHES GMBH TFNA SCREW 115MM - STERILE; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.115S
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2021
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.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 (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for the left femoral trochanteric fracture with the tfna screw in question.The 105mm screw was delivered to the hospital before the surgery, and the surgeon planned to use it.During the surgery, the surgeon measured the tfna screw length and the measuring value was 112mm.The longer tfna screw was not prepared, and the sales representative arranged the 115mm screw immediately.The 115mm screw was used.There was a surgical delay of more than sixty (60) minutes while awaiting arrival of the screw.The procedure was successfully completed.The patient outcome was stable.No further information is available.This report is for one (1) tfna screw 115mm - sterile.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: a device history record (dhr) review was conducted: part number:04.038.115s; synthes lot number: 9926238; supplier lot number: n/a; release to warehouse date: 25nov2015; expiration date: 30nov2025; manufactured by synthes elmira.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which 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.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.
 
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Brand Name
TFNA SCREW 115MM - STERILE
Type of Device
ROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key11604919
MDR Text Key280458930
Report Number8030965-2021-02534
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819652231
UDI-Public(01)07611819652231
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 03/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.038.115S
Device Lot Number9926238
Was Device Available for Evaluation? No
Date Manufacturer Received05/25/2021
Patient Sequence Number1
Treatment
UNK - NAIL HEAD ELEMENTS: SCREW.
Patient Age20 YR
Patient Weight80
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