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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG AIMING ARM ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG AIMING ARM ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.037.013
Device Problem Mechanical Jam (2983)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Reportedly there was no patient involvement. Event date: unknown date in 2018. Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been requested. 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 during inspection in the hospital on (b)(6) 2018, the blade/screw guide sleeve and the aiming arm were noted to be stuck together, and appeared to be damaged and bent. The blade/screw guide sleeve becomes stuck midway and does not pass freely through the hole of the aiming arm. The devices were eventually separated. There was no patient involvement. This is report 2 of 2 for (b)(4).
 
Manufacturer Narrative
A device history record (dhr) review was conducted for part: 03. 037. 013, lot: 9478544: manufacturing site: haegendorf, release to warehouse date: 14. Aug. 2015: the device history record shows this lot of 12 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process. Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition. Complainant device is not expected to be returned for manufacturer review/investigation. 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 Name130 DEG AIMING ARM
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 HAEGENDORF GMBH-CN
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7695301
MDR Text Key114408827
Report Number2939274-2018-52932
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
Report Date 06/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.013
Device Catalogue Number03.037.013
Device Lot Number9478544
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 Received08/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2015
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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