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	04/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review for part # 03.010.048 lot # 4944751.No ncr's were generated during production.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.Release to warehouse date: 2 mar 2005.Manufactured by synthes (b)(4).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 the three-part trocar combination which consisted of the protection sleeves, wire guides, and trocars was not lining up appropriately with the holes in the titanium (ti) lateral entry femoral recon nail-expert.Patient underwent a lateral entry femoral nail procedure for a left femur fracture on (b)(6) 2017.Surgeon reported that he was unable to accurately drill the holes for the two ti recon screws.In addition, surgeon stated that the aiming apparatus which consisted of the aiming arm and insertion handle was flimsy.Surgeon was able to manipulate the apparatus using his hands to get the trocar combination to line up appropriately and implant the recon screws.Additional x-rays were taken to get a better view of the issue.X-rays are not available for review.Procedure was successfully completed without requiring other medical intervention.There was an approximately 30 seconds to one minute surgical delay due to identifying the issue, multiple failed attempts, and hand manipulation.Patient status/outcome was reported as stable.Concomitant devices reported: ti lateral entry femoral nail (part 04.003.275s, lot h210044, quantity 1); ti recon screw (part 04.003.028, lot number unknown, quantity 2), drill bit (part 03.010.078, lot number unknown, quantity 1).This report is for one (1) locking aiming arm.This is report 5 of 5 for (b)(4).
Additional Manufacturer Narrative
A product development investigation was performed.The following eight (8) devices were received with surface wear consistent with the age of each device (approx.6.5 to 12.5 years old) and significant use and with the complaint category of ¿device interaction: misalignment.¿ -two (2) 11.5mm/8.5mm protection sleeves for recon locking (part 03.010.075 / lots 32739 x2 / mfg 03-aug-2004) -two (2) 8.5mm/3.2mm wire guides for recon locking (part 03.010.076 / lots 34696 x2/ mfg 09-nov-2004) -two (2) 3.2mm trocars for recon locking (part 03.010.077 / lot 37870 x2 / mfg 08 july2005/02-may-2007) -one (1) recon locking aiming arm for lateral entry femoral nails-ex (part 03.010.048 / lot 4944751 / mfg 02-mar-2005) -one (1) percutaneous insertion handle (part 03.010.046 / lot 3449695/ mfg 12-jul-2010) a device history record (dhr) review, device inspection, functional test, and drawing review were performed as part of this investigation.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.No new malfunctions were observed during the course of this investigation.The returned devices are part of the titanium cannulated lateral entry femoral nail system and are specifically used in targeting when the two recon locking screws option is desired.The associated nail was not returned; therefore testing with the nail in question was unable to be performed.However, during functional testing the devices could be fully assembled and formed a rigid construct as intended.In addition, the devices were found to not shows any defects which would contribute to the complaint condition.The observed surface wear was determined not impact functionality.Thus, the reported issue that the aiming apparatus was ¿flimsy¿ is unconfirmed.It was reported that the surgeon was able to manipulate the apparatus using his hands to get the trocar combination to line up appropriately and implant the recon screws and that the nail was successfully implanted.This speaks to the likelihood that the devices were not fully tightened as intended or that soft tissue deflection forces were present which would both impact the alignment.Relevant drawings, reflecting the current and manufactured revision, were reviewed.The recon locking protection sleeve holes of the aiming are were inspected and confirmed to be within the specification.In conclusion, as no functional issue was identified, the complaint condition for these devices is unconfirmed and could not be replicated.During the investigation there is no evidence of a manufacturing issue and no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.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: 6546390
• Report Number: 2530088-2017-10108
• Device Sequence Number: 1032843
• Product Code: FZX
• UDI-Device Identifier: 10886982067203
• UDI-Public: (01)10886982067203(10)4944751
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/09/2017

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: 4944751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2017
• Supplement Report FDA Received Date: 05/30/2017
• 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: DRILL BIT (03.010.078, LOT UNKNOWN, QTY 1); SCREW (04.003.028, LOT UNKNOWN, QTY 2)
• Patient Age: 19 YR
• Patient Weight: 64