MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX; GUIDE

Catalog Number	03.010.227
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number unavailable.Device is an instrument and is not implanted/explanted.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records 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
It was reported that, on (b)(6) 2018, the aiming arm for adolescent lateral entry femoral nail-ex was not aligning correctly during a surgical procedure to fix a proximal femur fracture on an adolescent.The surgeon mentioned that the distal recon screw hole that accepts the gold trocar, specifically, was not aligning.The procedure was completed using an adolescent lateral entry femoral nail.Patient outcome was not provided.Concomitant devices reported: 11.5mm/8.5mm protection sleeve (part#-03.010.075, lot#-unknown, quantity-1), 8.5mm/3.2mm guide wires/trocar (part#-03.010.076 , lot#-unknown, quantity-1), unknown femoral nail(part#-unknown, lot#-unknown, quantity-1).This is report 1 of 1 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.A device history record (dhr) review was conducted.Part: 03.010.227 , lot: 1962616 , manufacturing site: haegendorf , release to warehouse date: 11.Nov.2008.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 functional 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.A product investigation was conducted.Visual inspection: the aiming arm was received intact with overall surface wear.Small indents consistent with impact were observed over the surface of the device.No visual defects which would impact the functionality were noted.Functional test: replication of the complaint condition could not be completed as the mating devices were not received.The mating holes for the protection sleeves were inspected in the ¿dimensional inspection¿ section below.No defects were observed which would impact alignment.Therefore, the received condition does not support the complaint description as no defects were observed.Dimensional inspection: the two recon holes were inspected.The inner diameters both accepted a best fit gage pin which is within the specification per drawing.The two joined static and locking holes were also inspected.The inner diameters both accepted a best fit gage pin which is within the specification per drawing.Document/specification review: the relevant drawings, reflecting the current and manufactured revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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.The titanium cannulated adolescent lateral entry femoral nail surgical technique, , states to ¿confirm the nail is securely connected to the insertion handle using the 8mm ball hex screwdriver.¿ and cautions ¿do not exert forces on the aiming arm, protection sleeve, drill sleeve or drill bits.Such forces may prevent accurate targeting through the proximal locking holes and damage the drill bits.¿ no definitive root cause was able to be determined as circumstances surrounding the event and over the 9+ year lifespan of the device is unknown and no defects were identified on the returned device.Conclusion: the complaint condition could not be confirmed as no product defects were identified.No design or manufacturing defect or deficiency was observed during the investigation.No new malfunctions were observed during the course of this investigation.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: AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7868377
• Report Number: 2939274-2018-53733
• Device Sequence Number: 11247481
• Product Code: FZX
• UDI-Device Identifier: 10886982068095
• UDI-Public: (01)10886982068095
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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: 03.010.227
• Device Lot Number: 1962616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1