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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 03.037.010
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received. Reporter is a j&j representative. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; 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, the patient underwent for a surgery. During the surgery, the helical blade inserter had a piece broke off of the inserter. It was removed and put it back, but it is not staying well. We were able to put it back on and make it work, but it is not staying well. Also, the cannulated connecting screw threads are rough causing the removal of the insertion handle difficult. There were 10 minutes surgical delay. The procedure successfully completed. No patient consequence. Concomitant device reported: unk - insertion instruments (part# unknown; lot# unknown; quantity: 1). This complaint involves (3) devices. This report is for (1) cannulated connecting screw. This report is 2 of 3 for (b)(4).
 
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Brand NameCANNULATED CONNECTING SCREW
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12537262
MDR Text Key273561887
Report Number2939274-2021-05775
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.010
Device Catalogue Number03.037.010
Device Lot Number9919785
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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