MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

Catalog Number	357.369
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales consultant.A review of the device history records has been requested.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.
Event or Problem Description
It was reported that on (b)(6) 2018, helical blade inserter top screw (connecting screw) is not functioning properly.In addition, the buttress/compression nut does thread properly on a blade guide sleeve thread.The issues occurred during an unknown procedure.This report is for one (1) blade guide sleeve for trochanteric fixation nails.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
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 on (b)(6) 2018, helical blade inserter top screw (connecting screw) is not functioning properly, it won't screw in and lock the gold handle in places.In addition, the buttress/compression nut does thread properly on a blade guide sleeve thread, it gets stuck at the top of the guide sleeve.There was not patient involvement.This report is for one (1) blade guide sleeve for trochanteric fixation nails.This is report 1 of 4 for pc-(b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review conducted: part # 357.369.Synthes lot # 5512256.Supplier lot # na.Release to warehouse date: 02 jul 2007.Manufactured by synthes brandywine.No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was conducted.Visual inspection: the blade guide sleeve for trochanteric fixation nails (part # 357.369, lot # 5512256, mfg # 02-jul-2007) was received at us cq with the buttress/compression nut stuck at the top of the blade guide sleeve.There is deformation to the inner diameter of the blade guide sleeve and also some deformation can be seen on some of the threads.Functional test: the buttress/compression nut is stuck at the top of the blade guide sleeve and the two parts are unable to be separated.The complaint was not able to be replicated since the buttress nut cannot be unscrewed from the blade sleeve and screwed on again.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was completed, the threaded shaft diameter measured and is within specification based on relevant drawing.Document/specification review: the relevant drawing(s) was reviewed.Conclusion: the complaint condition is confirmed as the blade guide sleeve (part # 357.369, lot # 5512256) was received with the buttress nut stuck at the top.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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: BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8089775
• Report Number: 2939274-2018-55042
• Device Sequence Number: 1747557
• Product Code: FZX
• UDI-Device Identifier: 10886982196033
• UDI-Public: (01)10886982196033
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2018

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: 357.369
• Device Lot Number: 5512256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Initial Date Received by Manufacturer: 11/03/2018
• Supplement Date Received by Manufacturer: 12/27/2018; 12/27/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 12/31/2018; 12/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1