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

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).

• Brand Name: HELICAL BLADE INSERTER
• Type of Device: ROD, 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 Key: 7519720
• MDR Text Key: 108443130
• Report Number: 2939274-2018-52209
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070401
• UDI-Public: (01)10886982070401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.024
• Device Catalogue Number: 03.037.024
• Device Lot Number: T115113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1