MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS®/DCS® GUIDE SHAFT

Model Number	338.21
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exact date is unknown.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Reporter is synthes sales representative.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.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 or Problem Description
(b)(6) reports following: it was reported that on an unknown date, the depth gauge, handle with quick coupling, two (2) hexagonal screwdriver, and dynamic hip system/dynamic condylar system guide shaft were tagged as broken in medical device reprocessing department (mdrd).There were no patient or procedure involvement.This report is for one (1) dhs®/dcs® guide shaft.This is report 4 of 5 for (b)(4).
Additional 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.Date of event : unknown date in 2018.Part: 338.210 , lot: 1308 , manufacturing site: haegendorf.Dhr not available as device is older than 15 years.At this time the manufacturing documents for instruments had to be stored for 10 years.This was according to se_075477 (filing and archiving of specification documents) version ai, which was in place till august 2014.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.
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
Additional 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.Part: 338.210; lot: 1308; manufacturing site: haegendorf.Device history record (dhr) not available as device is older than 15 years.At this time, the manufacturing documents for instruments had to be stored for 10 years.Visual inspection: visual inspection of the returned device performed at customer quality (cq) observed significant post manufacturing damage, but not breakage.The distal tangs are bent torsionally and outward and there are nicks/dents resembling serrated teeth pliers on several areas of the device shaft.Therefore, the complaint is confirmed for the condition of deformation, which does not agree with the reported complaint condition of broken.Document/specification review: design drawing was reviewed during this investigation.The 338.21(0) dhs®/dcs® guide shaft is a reusable instrument routinely used in the dhs/dcs dynamic hip and condylar screw system.No product design issues or discrepancies were observed during this investigation.Dimensional inspection: the inside diameter at the damaged distal tip measured within specification per design drawing.The shaft outside diameter just proximal to the damaged distal tip measured within specification per design drawing.Material analysis: as the returned device is not broken, an analysis of material properties is not warranted.Conclusion: a definitive root cause for the post manufacturing damage could not be determined based on the provided information.The most likely causes are rough handling coupled with cumulative wear from over 15 years of service.This complaint is confirmed for deformation but not confirmed for the reported condition of breakage.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 as a result of this evaluation.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: DHS®/DCS® GUIDE SHAFT
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8025185
• Report Number: 2939274-2018-54705
• Device Sequence Number: 19170546
• Product Code: FZX
• UDI-Device Identifier: 10886982193247
• UDI-Public: (01)10886982193247
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/17/2018

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
• Operator of Device: Health Professional
• Device Model Number: 338.21
• Device Catalogue Number: 338.21
• Device Lot Number: 1308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 11/08/2018; 03/08/2019; 03/08/2019
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/27/2018; 03/12/2019; 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1