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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7 TI MULTILOC HUMERAL NAIL RT/CANN/240-S ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7 TI MULTILOC HUMERAL NAIL RT/CANN/240-S ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.016.240S
Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/23/2021
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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) 2021, patient underwent a surgical procedure, while inserting an interlocking multliloc screw, the screw was too short. The surgeon continued to try to insert the multiloc screw possible stripping out the plastic insert of the multiloc humeral nail. The screw was pulled out of the bone and nail, and abandoned that screw hole procedure was completed successfully with a five(5) minutes surgical delay. No patient consequence reported. Concomitant device reported: unk - insertion instruments: trauma (part# unknown; lot# unknown; quantity: 1). This report is for one (1) 7 ti multiloc humeral nail rt/cann/240-s. This is report 1 of 2 for complaint (b)(4).
 
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Brand Name7 TI MULTILOC HUMERAL NAIL RT/CANN/240-S
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12495719
MDR Text Key272175230
Report Number2939274-2021-05586
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120807
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 08/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.016.240S
Device Catalogue Number04.016.240S
Device Lot Number1L96879
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/20/2021 Patient Sequence Number: 1
Treatment
4.5 TI MULTILOC SCREW LENGTH 22-STERILE; UNK - INSERTION INSTRUMENTS: TRAUMA
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