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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-TAPPING 60MM; SCREW,FIXATION,BONE
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WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 60MM; SCREW,FIXATION,BONE Back to Search Results
Catalog Number 413.360S
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 (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-tapping 60mm.This report is 8 of 10 for (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).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: 413.360s, lot: 92p7693, manufacturing site: (b)(4), release to warehouse date: 26 april 2021, expiry date: 01 april 2031.A manufacturing record evaluation was performed for the finished device part: 413.360s, lot: 92p7693, and a non-conformance (b)(4) referred in the dhr was identified.The non conformance is related to head thread feature milled out of specification.An use as is was granted for this lot within the nr.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).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: 413.360s, lot: 92p7693, manufacturing site: (b)(4), release to warehouse date: 26 april 2021, expiry date: 01 april 2031.A manufacturing record evaluation was performed for the finished device part: 413.360s, lot: 92p7693, and a non-conformance (b)(4) referred in the dhr was identified.The non conformance is related to head thread feature milled out of specification.An use as is was granted for this lot within the nr.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-tapping 60mm.This report is 8 of 10 for (b)(4).
 
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Brand Name
5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 60MM
Type of Device
SCREW,FIXATION,BONE
Manufacturer (Section D)
WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ   4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13129917
MDR Text Key286017108
Report Number8030965-2021-10623
Device Sequence Number1
Product Code KTT
UDI-Device Identifier07611819268920
UDI-Public(01)07611819268920
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K974537
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
Date FDA Received12/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/01/2021
Device Catalogue Number413.360S
Device Lot Number92P7693
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2021
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 L70 TAN; LOCKSCR Ø5 SELF-TAP L80 TAN; LOCKSCR Ø5 SELF-TAP L90 TAN; TOMOFIXTIBHEADPL MED PROX 4HO TI
Patient Outcome(s) Required Intervention;
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