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-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2018

Event Type  malfunction  

Manufacturer Narrative

Device is not expected to be returned for manufacturer review/investigation.Device history records review was completed for part: 03.037.026, lot: 9381269.Manufacturing location: (b)(4), release to warehouse date: feb 18, 2015.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on an (b)(6) 2018, during an unknown procedure, while the scrub tech assembled the components during surgery, it was discovered that the screw inserter coupling cannot thread into cannula properly and the helical blade does not thread inside of inserter.Another set was open.Procedure was completed successfully with no delay.Patient outcome was unaffected.There was no patient consequence.This report is for one (1) helical blade/screw coupling screw.This is report 2 of 2 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.H10 additional narrative: device history lot, part: 03.037.026, lot: 9381269, manufacturing site: bettlach, release to warehouse date: 18.Feb.2015.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Visual inspection: visual inspection performed on the returned instrument revealed damaged proximal threads which will prevent the device from functioning as intended.The balance of the device is in fair condition.Functional test: the connecting screw was tested with the returned inserter and the connector would not insert fully onto the inserter without the use of force.The complaint condition does agree with the received condition of the device.The complaint could be replicated with the returned device.Dimensional inspection: dimensional analysis was not performed as the relevant features are deformed.Document/specification review : no design or manufacturing defect or deficiency was observed during the investigation.Investigation conclusion: while no definitive root cause could be determined it is possible that the device encountered unintended forces.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 8174150
• MDR Text Key: 130768711
• Report Number: 2939274-2018-55440
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070425
• UDI-Public: (01)10886982070425
• 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: 11/22/2018

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: 9381269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Manufacturer Received: 11/22/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1