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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SLIDING CARRIAGE TRACTION,APPARATUS,NON-POWERED

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SLIDING CARRIAGE TRACTION,APPARATUS,NON-POWERED Back to Search Results
Catalog Number 394.43
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
No patient involvement reported. Date of event is unknown. Device is an instrument and is not implanted / explanted. Product development investigation was completed. Visual inspection of the returned device performed at customer quality (cq) confirmed the condition of two devices being stuck together, which agrees with the reported complaint condition. The two devices were unable to be separated at cq. Therefore, the reported complaint condition is confirmed and was able to be replicated at cq. Relevant drawings were reviewed during this investigation. Based on the etchings on the device, it can be determined that it was made prior to the oldest available drawings for this part in synthes systems. Based on the etchings on the returned device, it can be determined that it was made prior to may 21, 1999. Therefore, it is over 19 years old. No product design issues or discrepancies were observed. Device history records review could not be completed as device was manufactured before 1998. A relevant dimensional inspection could not be performed at cq because the features of interest are not accessible as the two devices were returned stuck together. A definitive root cause for the devices becoming stuck together could not be determined based on the provided information. The most likely cause is over tightening leading to a cross threading situation. This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation. No new, unique or different patient harms were identified as a result of this evaluation. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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
(b)(6) reports following: it was reported that during sterile processing department (spd) inspection on an unknown date, the sliding carriage was noted to be cross threaded and seized on two (2) holding sleeves and a schanz screw blunted trocar. There was no patient involvement. During manufacturing investigation, the condition of two devices being stuck together was confirmed, which agrees with the reported complaint condition. This report is for one (1) sliding carriage. This is report 2 of 2 for (b)(4).
 
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Brand NameSLIDING CARRIAGE
Type of DeviceTRACTION,APPARATUS,NON-POWERED
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7841673
MDR Text Key119039097
Report Number2939274-2018-53574
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number394.43
Device Lot Number2019.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2018
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 Unkown

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