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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.037.024
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
There was no known reported patient involvement associated with the complained event. Date of event is unknown device is an instrument and is not implanted/explanted. A device history record (dhr) review was performed for part number: 03. 037. 024, synthes lot number: t115113: release to warehouse date: 07-may-2015, manufacture site: tuttlingen, part expiration date: n/a, list of nonconformance¿s: n/a: a review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition. No non-conformance reports (ncrs) were generated during the production of this device. Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. A product investigation was conducted. The helical blade inserter (part: 03. 037. 024, lot: t115113, mfg: 07-may-2015) was received with the reported condition of ¿unable to assemble: nrm". At customer quality, the returned helical blade inserter (part: 03. 037. 024, lot: t115113, mfg: 07-may-2015) was inspected and the complaint was confirmed. Visual inspection performed at customer quality observed that the distal cannulation diameter has scratched patterns caused by mating device (coupling screw). Additionally, during the functional inspection performed at customer quality it was observed that the coupling screw could not completely advance into the inserter. Therefore, the complaint condition was confirmed. Complaint condition was able to be replicated at the customer quality and the complaint was confirmed. Relevant drawings for the returned device were reviewed (both current and from the time of manufacture): top-level drawing for tfna blade inserter and shaft for inserter drawing and determined to be suitable for the intended design and application when used as recommended. Dimensional analysis performed on the cannulation diameter accepted that gage pin falls out of the specifications per relevant drawing. The out of specification measurements is due to the post manufacture damage. A device history review was performed for the returned instrument¿s lot number and no ncrs, mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition. 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 usage and handling could have contributed to scratched cannulation of the device. Also, it was identified that the coupling screw used with this inserter has a flared solid portion. The flared solid portion of coupling screw when used with mallet force during its insertion into the inserter would have caused the deformed patterns in the cannulation. The deformed/scratched patterns of device cannulation contributed to complaint condition of the device. 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.
 
Event Description
It was reported that following a successful trochanteric fixation nail-advanced (tfna) procedure it was discovered that a helical blade inserter and connecting screw would not screw back together. This discovery was made as the sales consultant and hospital staff were resetting the tray. The sales consultant reported noticing that the threads seemed to be stripped. He is unsure when or how this occurred. There was no patient or procedure involvement. During manufacturer¿s investigation process of the returned helical blade inserter it was observed that the distal cannulation diameter has scratched patterns caused by mating device (coupling screw). Additionally, during the functional inspection performed at customer quality it was observed that the coupling screw could not completely advance into the inserter. This complaint condition was re-evaluated and determined to be reportable on (b)(6) 2018. This report is for one (1) helical blade inserter. This is report 2 of 2 for complaint (b)(4).
 
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Brand NameHELICAL BLADE INSERTER
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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7519720
MDR Text Key108443130
Report Number2939274-2018-52209
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
Report Date 03/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.024
Device Catalogue Number03.037.024
Device Lot NumberT115113
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2015
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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