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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Reporter is synthes sales representative.The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review has been requested.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 unknown date, the inner threads of the proximal femoral nailing system (tfna) helical blade quick coupling and lag screw quick coupling were deformed, preventing the helical blade or screw from fully threading on.There was no patient or procedure involved.Concomitant devices: helical blade (part unknown, lot unknown, quantity1).This report is for one (1) helical blade/screw coupling screw.This is report 1 of 2 for pc-(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.H3, h4, h6: dhr review: device history part: 03.037.026, lot: 9116171, manufacturing site: bettlach , release to warehouse date: 24.Nov.2014.The device history record shows this lot of (b)(4) pieces 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.Device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.The returned device was manufactured in november 2014 at bettlach manufacturing site.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual 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.H3, h6: investigation summary background: it was reported that on an unknown date, the inner threads of the proximal femoral nailing system (tfna) helical blade quick coupling and lag screw quick coupling were deformed, preventing the helical blade or screw from fully threading on.There was no patient or procedure involved.Investigation flow: damage: visual (appearance not as expected) visual inspection: visual inspection performed at customer quality (cq) under 10x magnification on the received connecting screw showed stripped threads proximal to its head.No new issues were observed other than the normal signs of wear which will not affect the product functionality.Dimensional inspection:/document/specification review: a relevant dimensional inspection was performed.The distal end of connecting screw had diameter of 5.33mm and dimensional inspections were completed.This is within the specification per drawing.Dimensional inspection performed on the relevant deformed thread dimensions measured the outer diameter as is out of the specification.The obtained out of specification is due to post manufacture damage to threads.Was the complaint confirmed? yes.Conclusion: a definitive root cause could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.

• 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: 8117047
• MDR Text Key: 128926444
• Report Number: 2939274-2018-55162
• 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
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• 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: 9116171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1