MAUDE Adverse Event Report: SYNTHES BRANDYWINE RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX; GUIDE

Catalog Number	03.010.048
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant and explant dates: 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.No service history review can be performed as part number 03.010.048 with lot number(s) 5753221 is a lot/batch controlled item.The manufacture date of this item is april 03, 2008.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Part 03.010.048, synthes lot 5753221: release to warehouse date: april 03, 2008.Manufactured by: (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 an aiming arm would not line up properly with a nail and a depth gauge wasn¿t sliding correctly during a right lateral entry femoral nailing and left distal radius open reduction internal fixation (orif) on (b)(6) 2017.As the surgeon was trying to drill one of the proximal holes, the guide (aiming arm) on the side of insertion handle was not lining up properly.The surgeon loosened it and angled it until it went through the nail.There was no reported surgical delay.Also, during a left distal radius orif during the same procedure, a depth gage wasn¿t sliding correctly; the sleeve seemed loose.There was a one minute delay depth to open another set to retrieve another gauge.The patient¿s final constructs included: one femoral nail, three (3) 5.0mm locking screws, one (1) distal radius plate and eight (8) screws, a mix of three (3) 2.4 cortex and five (5) 2.4 variable angle (va) locking.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: stryker power drill (part/lot unknown, quantity 1), drill bit (part 03.0101.061, lot unknown, quantity 1); femoral nail (part 04.003.356s, lot h210410, quantity 1); distal radius plate (part 02.111.631, lot unknown, quantity 1); 2.4mm cortex and 2.4mm variable angle (va) locking screws (parts/lots unknown, quantity 8); cannulated connecting screw for standard insertion handle (part 03.010.044, lot 1485564, quantity 1); standard insertion handle (part 03.010.045, lot 1485564, quantity 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Service and repair evaluation was completed.The customer reported the aiming arm was not lining up ideally with the nail.The repair technician reported the aiming arm was out of alignment.Nonfunctional item(s) is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Product development investigation was completed.A device history review (dhr), device inspection, functional test and drawing review were performed as part of this investigation.This complaint is unconfirmed for the aiming arm not lining up properly with a nail.The complaint is non-replicable for the aiming arm alignment to the nail because not enough information was given in the complaint description.No new malfunctions were identified during this investigation.Fully functional testing of the aiming arm could not be performed due to lack of instruments available.Relevant drawings were reviewed.The 03.010.048 recon aiming arm is used in conjunction with the standard insertion handle 03.010.045 and is used for correct placement of the proximal locking screws and placement of the 6.5mm titanium recon screws, 04.003.022 through 04.003.036 per technique guide titanium cannulated entry femoral recon nail.The root cause of the complaint could not be determined from the drawing.The part matched the print.No discrepancies were observed that may have contributed to the complaint condition.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: RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6807260
• Report Number: 2530088-2017-10255
• Device Sequence Number: 992119
• Product Code: FZX
• UDI-Device Identifier: 10886982067203
• UDI-Public: (01)10886982067203(10)5753221
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2017

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: 03.010.048
• Device Lot Number: 5753221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 09/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR