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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING HEAD SCREW SELF-DRILLING 80 MM; APPLIANCE, FIXATION, NAIL
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WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING HEAD SCREW SELF-DRILLING 80 MM; APPLIANCE, FIXATION, NAIL Back to Search Results
Catalog Number 413.380S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Date 01/01/2021
Event Type  Injury  
Event Description
Device report from synthes reports an event in netherlands as follows: it was reported on an unknown date that the patient had infection after a tomofix surgery.It was unknown if there is any schedule for further procedure.The patient has consequences are reported.This complaint involves ten(10) devices.This report is for (1) 5.0mm ti locking head screw self-drilling 80 mm this report is 5 of 10 for (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: event year is reported as 2021; however exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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: 413.380s, lot: 95p7209, manufacturing site: (b)(4), release to warehouse date: 26 march 2021, expiry date: 01 march 2031.A manufacturing record evaluation was performed for the finished article lot and no non-conformances 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.
 
Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: event year is reported as 2021; however exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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: 413.380s, lot: 95p7209, manufacturing site: (b)(4), release to warehouse date: 26 march 2021, expiry date: 01 march 2031.A manufacturing record evaluation was performed for the finished article lot and no non-conformances 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 on an unknown date that the patient had infection after a tomofix surgery.It was unknown if there is any schedule for further procedure.The patient has consequences are reported.This complaint involves ten(10) devices.This report is for (1) 5.0mm ti locking head screw self-drilling 80 mm this report is 5 of 10 for (b)(4).
 
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Brand Name
5.0MM TI LOCKING HEAD SCREW SELF-DRILLING 80 MM
Type of Device
APPLIANCE, FIXATION, NAIL
Manufacturer (Section D)
WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ   2540
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13129899
MDR Text Key285681191
Report Number8030965-2021-10620
Device Sequence Number1
Product Code KTT
UDI-Device Identifier07611819268968
UDI-Public(01)07611819268968
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K023941
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
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 Catalogue Number413.380S
Device Lot Number95P7209
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/06/2021
Initial Date FDA Received12/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2021
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
CORTSCR Ø4.5 SELF-TAP L50 TI; LOCKSCR Ø5 SELF-DRILL L26 TAN; LOCKSCR Ø5 SELF-DRILL L26 TAN; LOCKSCR Ø5 SELF-DRILL L26 TAN; LOCKSCR Ø5 SELF-TAP L48 TAN; LOCKSCR Ø5 SELF-TAP L60 TAN; LOCKSCR Ø5 SELF-TAP L70 TAN; LOCKSCR Ø5 SELF-TAP L90 TAN; TOMOFIXTIBHEADPL MED PROX 4HO TI
Patient Outcome(s) Required Intervention;
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