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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPLETE RADIOLUCENT INSERTION HANDLE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.037.012
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/23/2018
Event Type  malfunction  
Manufacturer Narrative
Patient¿s height reported as 5 feet 7 inches. Device is an instrument and is not implanted/explanted. The subject device has been received and the product evaluation is in progress. No conclusion can be drawn. A review of the device history records has been requested and is currently pending completion. 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 an initial surgery for trochanteric nail fixation ¿ advanced (tfna), was performed on (b)(6) 2018. During the surgery, as the surgeon attempted to align the nail with the insertion handle, the distal tang of the insertion handle was found to be bent. A new insertion handle was retrieved from another set to complete the procedure which caused a 5-minute surgical delay. The surgery was completed successfully and the patient is reported to be in stable condition. Concomitant devices reported: tfna nail (part number unknown, lot number unknown, quantity 1). This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
A device history record (dhr) review was performed for part no. : 03. 037. 012, lot no. : 9362070: manufacturing location: (b)(4), release to warehouse date: 12. Mar. 2015: no non-conformance reports (ncrs) were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. A product investigation was performed. The returned insertion handle (part: 03. 037. 012, lot: 9362070, mfg: 12-mar-2015) was inspected at customer quality and the complaint of bent tip was confirmed. Visual inspection performed at customer quality observed that the tip of the insertion handle was bent both outward and sideways. No new malfunction was identified. Whether this complaint could be replicated is not applicable because the device was returned bent. Relevant drawings for the returned device were reviewed (both current and from the time of manufacture): top-level drawing for insertion handle and determined to be suitable for the intended design and application when used as recommended. Dimensional analysis performed for the width of the distal tab of the insertion handle measured and is within specifications. Also, based on the device history record review, there is no indication that any issues with material or material properties contributed to the complaint condition. While no definitive root cause could be determined it is possible that any unintended forces encountered by the device during its usage or handling could have led to the complaint condition. During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition. 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.
 
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Brand NameCOMPLETE RADIOLUCENT INSERTION HANDLE
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 Key7363931
MDR Text Key103281337
Report Number2939274-2018-51187
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
Type of Report Initial,Followup
Report Date 02/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.012
Device Catalogue Number03.037.012
Device Lot Number9362070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/12/2015
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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