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

Model Number 03.037.026

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

Reportedly there was no patient involvement.Date of event is unknown.Implant and explant date is not applicable.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).A device history record review was requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 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.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part no.: 03.037.026, lot no.: 9560695: manufacturing location: bettlach, release to warehouse date: 09.Jul.2015: no 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 conducted.The helical blade/screw coupling screw (part: 03.037.026, lot: 9560695, mfg: 09-jul-2015) was received with the reported condition of ¿unable to assemble: rm.¿ at customer quality, the returned helical blade/screw coupling screw (part: 03.037.026, lot: 9560695, mfg: 09-jul-2015) was inspected and the complaint was confirmed.Visual inspection performed at customer quality observed that the distal threads of the coupling screw were nicked and deformed.Additionally, the solid portion of the shaft closer to distal threads was observed to be slightly flared due to nicked deformation.Furthermore, functional inspection performed at customer quality observed that coupling screw could not be completely advanced into the inserter.The coupling screw was observed to be stuck at its flared portion of the solid shaft.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 connecting screw for blade/screw and determined to be suitable for the intended design and application when used as recommended.Dimensional analysis was performed on the different following portions of the device: the dimensional analysis performed on the deformed threads measured and falls within the specifications and tolerance specified per relevant drawing.Additionally, dimensional analysis performed on the sold shaft portion proximal to distal threads measured and falls within the specifications and tolerance specified per relevant drawing.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 the any unintended forces encountered by the device during usage and handling could have contributed to deformed threads and flared portions of the device.The deformed threads and flared portions of device 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.

• Brand Name: HELICAL BLADE/SCREW COUPLING SCREW
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7425446
• MDR Text Key: 105680087
• Report Number: 2939274-2018-51614
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070425
• UDI-Public: (01)10886982070425(10)9560695
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• 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: 03.037.026
• Device Catalogue Number: 03.037.026
• Device Lot Number: 9560695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1