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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0 TI LCKNG SCR T25 SD 38 FOR IM NAILS; SCREW, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0 TI LCKNG SCR T25 SD 38 FOR IM NAILS; SCREW, FIXATION, BONE Back to Search Results
Model Number 02.240.038
Device Problem Migration (4003)
Patient Problem Ulcer (2274)
Event Date 02/28/2022
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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
It was reported that on (b)(6) 2022, the tfna hardware was removed due to the implant failing.The implant had cut through and had created an ulcer on the patient¿s lateral side.The implant was intact and no fragments were created.The patient was revised with a total hip arthroplasty (tha).This report involves one (1) 3.7mm cannulated locking screw 38mm.This is report 3 of 3 for (b)(4).
 
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Brand Name
5.0 TI LCKNG SCR T25 SD 38 FOR IM NAILS
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 GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ   2540
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13940163
MDR Text Key288124125
Report Number2939274-2022-01118
Device Sequence Number1
Product Code HWC
UDI-Device Identifier10886982085962
UDI-Public10886982085962
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172157
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,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 Model Number02.240.038
Device Catalogue Number04.005.528
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/28/2022
Initial Date FDA Received03/29/2022
Supplement Dates Manufacturer Received06/21/2022
Supplement Dates FDA Received07/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
9/130 DEG TI CANN TFNA 235/LEFT - SILE; TFNA HELICAL BLADE 95MM
Patient Outcome(s) Required Intervention;
Patient Weight66 KG
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