Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 4.0MM TI CANCELLOUS BONE SCREW FULLY THREADED/14MM; PASSER
  • 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 4.0MM TI CANCELLOUS BONE SCREW FULLY THREADED/14MM; PASSER Back to Search Results
Catalog Number 406.014S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Type  Injury  
Manufacturer Narrative
Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/ investigation.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: part: 406.014s, lot: 4l52542, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: may 06, 2019, expiry date: april 01, 2029.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: part number: 406.014, lot number: 3l83055, manufacturing site: (b)(4), release to warehouse date: march 15, 2019.A manufacturing record evaluation was performed for the non-sterile device lot number, and no non-conformance were identified.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 the patient was operated with an osteosynthesis on the inferior limbs in (b)(6) 2020.Since (b)(6) 2020, the patient had an allergy.No further information provided.This report is for one (1) 4.0mm ti cancellous bone screw fully threaded/14mm.This is report 5 of 10 for complaint (b)(4).This complaint involves total 13 devices.Additional 03 devices are reported under the related complaint (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.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
The adverse event was discovered one (1) month after the primary surgery.There is no revision surgery scheduled at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
4.0MM TI CANCELLOUS BONE SCREW FULLY THREADED/14MM
Type of Device
PASSER
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10938123
MDR Text Key219316522
Report Number8030965-2020-09339
Device Sequence Number1
Product Code HWQ
UDI-Device Identifier07611819134232
UDI-Public(01)07611819134232
Combination Product (y/n)N
PMA/PMN Number
K925351
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number406.014S
Device Lot Number4L52542
Was Device Available for Evaluation? No
Date Manufacturer Received12/03/2020
Patient Sequence Number1
Treatment
CANCELLOUSSCR Ø4 FULL-THR L18 TI; CANCELLOUSSCR Ø4 L50/15 TI; CORTSCR Ø3.5 SELF-TAP L14 TI; CORTSCR Ø3.5 SELF-TAP L14 TI; CORTSCR Ø3.5 SELF-TAP L14 TI; CORTSCR Ø3.5 SELF-TAP L26 TI; CORTSCR Ø3.5 SELF-TAP L45 TI; CORTSCR Ø3.5 SELF-TAP L55 TI; LCP ONE-THIRD TUBULAR PLATE 3.5, 6 HOLES; CANCELLOUSSCR Ø4 FULL-THR L18 TI; CANCELLOUSSCR Ø4 L50/15 TI; CORTSCR Ø3.5 SELF-TAP L14 TI; CORTSCR Ø3.5 SELF-TAP L14 TI; CORTSCR Ø3.5 SELF-TAP L14 TI; CORTSCR Ø3.5 SELF-TAP L26 TI; CORTSCR Ø3.5 SELF-TAP L45 TI; CORTSCR Ø3.5 SELF-TAP L55 TI; LCP ONE-THIRD TUBULAR PLATE 3.5, 6 HOLES
Patient Outcome(s) Required Intervention;
-
-