MAUDE Adverse Event Report: SYNTHES HAGENDORF AIM-ARM 125° F/STAT+DYN DIST LOCK; ROD,FIXATION,INTRAMEDULLARY

Catalog Number	03.037.114
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported during a femoral trochanteric fracture procedure utilizing the proximal femoral nailing system (tfna) on (b)(6) 2017, surgeon had difficulty inserting the helical blade.Surgeon continued the insertion process as it was believed the patient bone quality was good.It was then noted the 125 degree aiming arm had been connected to the nail instead of the 130 degree aiming arm.Surgeon was unable to remove the helical blade because the protection sleeve was tensioned, so insertion of the blade continued.Once the helical blade was inserted, surgeon was not able to remove the protection sleeve from the aiming arm.The aiming arm was then detached from the nail.As a result of detaching the aiming arm, surgeon was then unable to reattach the aiming arm to the already inserted nail.Surgeon then opted to not implant the screw.Surgery was completed with a delay of approximately 40 minutes.No patient harm or other medical intervention was reported.Concomitant devices reported: hammer (part number unknown, lot number unknown, quantity 1), 130 degree aiming arm (part number unknown, lot number unknown, quantity 1), screw (part number unknown, lot number unknown, quantity 1), insertion handle (03.037.011, lot 9753604, quantity 1), connection screw (03.037.010, lot 9751151, quantity 2), buttress/compression nut (03.037.016, lot 9662892, quantity 1), guide sleeve (03.037.017, lot l137831, quantity 1), wire guide sleeve (03.037.018, lot 9700784, quantity 1), drill bit (03.037.021, lot f-18869, quantity 1), tfna helical blade impactor (03.037.024, lot t127814, quantity 1) this report is for one (1) 125 degree aiming arm.This is report 2 of 3 for (b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 03.037.114, lot# 9663766.Manufacturing location: (b)(4), manufacturing date: jan 05, 2016.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.One aiming arm part# 03.037.114, lot# 9663766 was returned and was tested for functionality.In order to perform the handling test, the following article was used in conjunction: art: 03.037.113 / aim-arm 130° f/stat+dyn dist lock.Pd assessment concluded that there was no problem using the 130° aiming arm in combination with said 130 ° im nail.No further investigation were taken as the functional test showed that the returned articles together with additional used aim-arm 130° and 130° im nail did work as intended.When assembling the aim-arm 125° like reported in the complaint description the functionality was not given.Therefore we do conclude that the described problems throughout surgery might have happened and do confirm this complaint.No manufacturing related failure was found.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.
Additional Manufacturer Narrative
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 medical devices reported: hammer (part number unknown, lot number unknown, quantity 1), 130 degree aiming arm (part number unknown, lot number unknown, quantity 1), screw (part number unknown, lot number unknown, quantity 1), connection screw (03.037.010, lot 9751151, quantity 2), drill bit (03.037.021, lot f-18869, quantity 1), tfna helical blade impactor (03.037.024, lot t127814, quantity 1), helical blade/screw coupling screw (03.037.026, lot 9768861, quantity 1).

• Brand Name: AIM-ARM 125° F/STAT+DYN DIST LOCK
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6570604
• Report Number: 3003875359-2017-10233
• Device Sequence Number: 10785605
• Product Code: HSB
• UDI-Device Identifier: 07611819642676
• UDI-Public: (01)07611819642676(10)9663766
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2017

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: 03.037.114
• Device Lot Number: 9663766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 06/15/2017; 06/23/2017
• 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: AIMING ARM (PART AND LOT UNKNOWN, QTY 1); BLADE IMPACTOR (03.037.024, LOT T127814, QTY 1); CONNECTION SCREW (03.037.010, LOT 9751151, QTY 2); DRILL BIT (03.037.021, LOT F-18869, QTY 1); GUIDE SLEEVE (03.037.017, LOT L137831, QTY 1); INSERTION HANDLE (03.037.011, LOT 9753604, QTY 1); NUT (03.037.016, LOT 9662892, QTY 1); SCREW (PART AND LOT UNKNOWN, QTY 1); WIRE GUIDE SLEEVE (03.037.018, LOT 9700784,QTY 1)