MAUDE Adverse Event Report: SYNTHES MONUMENT PERCUTANEOUS AIMING ARM FOR LAT ENTRY F/FEMORAL NAIL RECON; GUIDE

Catalog Number	03.010.403
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient weight not provided for reporting.Device is an instrument and is not implanted/explanted.Concomitant devices reported: cann connecting scr f/percutaninstruments for nails-ex (part # 03.010.404, lot # u238759, quantity # 1).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: dhr review part number: 03.010.403.Synthes lot number: 6132690.Supplier lot number: 1717700.Release to warehouse date: 19-may-2009.Expiration date: n/a.Supplier: (b)(4).Ncr was generated during production of 20 parts.One part had incorrect dimensions and 2 parts were missing etching.Upon re-examination with a higher degree of accuracy the parts measured within drawing requirements.Relevance to complaint condition cannot be determined until the product is returned for investigation.Review of the device history record showed that there are potential issues during the manufacture of this product which would contribute to this complaint condition.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 during initial intramedullary nailing (tfn-advanced) of a femur procedure on (b)(6) 2017, after the surgeon prepped the patient for the nail, the certified scrub technician (cst) tested the alignment of the percutaneous insertion handle for femoral nails and a percutaneous aiming arm (both for lateral entry femoral nails) prior to the continuation of the surgery.The insertion handle and aiming arm did not line up while using only a cannulated connecting screw in the construct.The surgeon had to switch back to the standard handle (tfn; trochanteric fixation nail) to complete the procedure.There was 3 minutes delay in surgery.Procedure was completed successfully and patient status was reported as fine.This complaint involves 2 devices.Concomitant devices reported: cann connecting scr f/percutaninstruments for nails-ex (part # 03.010.404, lot # u238759, quantity # 1).This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
The returned insertion handle (03.010.401) was able to be attached to the returned aiming arm (03.010.403) with no issues.The devices were found to have surface wear which does not impact functionality.The connecting screw (03.010.404) fits appropriately with the insertion handle.No functional issues were observed with the returned devices.Based on the complaint description, the determination that a misalignment existed was made without a nail present.The complaint was not confirmed and was not able to be replicated.The devices align and interact appropriately therefore further investigation is not necessary.The following concomitant part (part #: 03.010.404, lot #: u238759) was returned with no allegation against it.The device shows normal surface wear which does not impact functionality.No other issues were noted with the connecting screw therefore further investigation is not required.Drawing and dhr review: the design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No additional malfunctions were observed during investigation.No definitive root cause was able to be determined.The complaint condition was not confirmed or replicated.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: PERCUTANEOUS AIMING ARM FOR LAT ENTRY F/FEMORAL NAIL RECON
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6984057
• Report Number: 1719045-2017-11121
• Device Sequence Number: 18962541
• Product Code: FZX
• UDI-Device Identifier: 10886982068552
• UDI-Public: (01)10886982068552(10)1717700
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/02/2017

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: 03.010.403
• Device Lot Number: 1717700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR