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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FRN; ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FRN; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.033.001
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/12/2021
Event Type  malfunction  
Manufacturer Narrative
The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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
It was reported that on (b)(6) 2021, patient underwent an orthopedic procedure.The surgeon was inserting a rt femoral recon nail, while inserting the nail the driving cap sheared off and fell on the floor.The threaded portion broke off in the insertion handle.The surgeon used a screwdriver to finish inserting the nail without delay and completed the case without any further issues.No fragments generated and no patient consequences noted.This report involves one (1) radiolucent insertion handle frn.This is report 2 of 2 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: h3, h4, h6- the complaint condition was not confirmed as no damage were observed on the radiolucent insertion handle frn (p/n: 03.033.001, lot # 5p3869).There is no indication that a design or manufacturing issue were identified.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part number: 03.033.001 lot number: 5p3869 part/lot combination is unknown at jabil (in epr sap p02), no dhr review possible for group "synthes trauma - mfg - dhr - hagendorf".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
RADIOLUCENT INSERTION HANDLE FRN
Type of Device
ROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
BRANDYWINE
1303 goshen parkway
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12591770
MDR Text Key275242712
Report Number2939274-2021-05953
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982271051
UDI-Public(01)10886982271051
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
Report Date 09/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number03.033.001
Device Catalogue Number03.033.001
Device Lot Number55P3869
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/12/2021
Initial Date FDA Received10/07/2021
Supplement Dates Manufacturer Received10/29/2021
Supplement Dates FDA Received11/07/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
DRIVING CAP F/INSERTION HANDLE; UNK - NAILS: FEMORAL; DRIVING CAP F/INSERTION HANDLE; UNK - NAILS: FEMORAL
Patient Age20 YR
Patient SexMale
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