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

Model Number	357.369
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 or Problem Description
It was reported that on an unknown date during an unknown procedure, the buttress compression nut for blade sleeve for trochanteric fixation nails got stuck together.The blade guide sleeve trochanteric fixation nail failed.The buttress nut and guide sleeve impacted in patient.An unknown mallet was used to remove the damaged sleeve and buttress nut.There was a surgical delay of five (5) minutes.The procedure was completed successfully.The patient outcome was unknown.Concomitant device reported: unknown impaction inst: hammer/mallet: trauma (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This report is for one (1) blade guide sleeve for trochanteric fixation nails.This is report 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5: updated concomitant devices.H3, h6: the device has been 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
Concomitant device reported: impaction inst: hammer/mallet: trauma (part#: unknown, lot#: unknown, quantity: 1); buttress/compression nut for 357.369 (part #: 357.371, lot #: 4987428, quantity: 1).
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.Visual inspection: the blade guide sleeve for trochanteric fixation nails (part # 357.369/ lot # unk) was received at us customer quality (cq).The lot number was not able to be determined as the buttress nut covered majority of the number.The threaded portion of the guide sleeve proximal to the mated buttress nut was stripped and deformed.There were scratches along the body of the guide sleeve.Functional test: functional testing was performed with the returned devices.The buttress/compression nut was not able to be disassembled from the mated guide sleeve.The buttress nut was not able to further loosen/tighten.Due to the stripped condition of the threads, its possible the mating threads were cross threaded.The overall complaint was confirmed.Can the complaint be replicated with the returned device(s)? yes.Dimensional inspection: dimensional inspection could not be confirmed as device disassembly to access internal components was not possible.Document/specification review: drawing(s) reviewed: since the exact date of manufacture was not determined, the current revision of the drawing was reviewed.Conclusion: the overall complaint was confirmed for the received blade guide sleeve for trochanteric fixation nails as the device was not able to disassemble from the buttress nut.Although no definitive root-cause can be determined its possible the devices have galled together or are cross threaded.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 10146057
• Report Number: 2939274-2020-02785
• Device Sequence Number: 3300360
• Product Code: FZX
• UDI-Device Identifier: 10886982196033
• UDI-Public: (01)10886982196033
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2020

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: 357.369
• Device Catalogue Number: 357.369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 05/30/2020
• Supplement Date Received by Manufacturer: 06/11/2020; 07/07/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 06/26/2020; 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BUTTRESS/COMPRESSION NUT FOR 357.369.; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA.
• Patient Weight: 64