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

Catalog Number	338.23
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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
It was reported that four (4) interlocking bolts were found to be stripped.The two prongs on either side of the guide shaft was bent.As a result, the coupling screw became stripped.This was discovered when the set was put together during sterile processing on (b)(6) 2018.There was no patient involvement reported.This report is for one (1) dhs®/dcs® guide shaft with flats.This is report 1 of 1 for complaint (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.Additional narrative: device history record (dhr) review: part # 338.23; synthes lot # ft00310; supplier lot # ft00310; release to warehouse date: 26jan2017; supplier: flextronics america llc.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.Investigation summary: investigation flow: damage: visual (appearance not as expected) visual inspection: visual inspection performed at customer quality (cq) confirmed the condition of a bent device, which agrees with the reported complaint condition.Both of the distal tangs are bent torsionally.Document/specification review: the returned device was manufactured in january 2017.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.Design drawing was reviewed during this investigation.The 338.23 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.Dimensional inspection: the inside diameter at the distal tip near bent tangs measured ø5.04mm at cq (gp29) which is within specification of ø5.1mm +/-0.1mm per design drawing.The outside diameter at the distal tip near bent tangs measured ø7.75mm at cq (ca592) which is within specification of ø7.8mm +0/-0.1mm per design drawing.The outside flat to flat diameter at the distal tip near bent tangs measured ø7.06mm at cq (ca592) which is within specification of ø7.1mm +0/-0.1mm per design drawing.Conclusion: a definitive root cause for the bent condition could not be determined based on the provided information.The most likely cause for the bent condition is rough handling and excessive force.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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H11: corrected data: d10: device was returned to manufacturer on 6/13/2018 as opposed to 6/18/2018 reported in mwr-18062018-0000131824.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 WITH FLATS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7622521
• Report Number: 2939274-2018-52569
• Device Sequence Number: 2067090
• Product Code: FZX
• UDI-Device Identifier: 10886982193278
• UDI-Public: (01)10886982193278
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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 Catalogue Number: 338.23
• Device Lot Number: FT00310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1