MAUDE Adverse Event Report: SYNTHES HAGENDORF AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX; GUIDE

Catalog Number	03.010.227
Medical Device Problem Codes	Component Missing (2306); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: there was no reported patient involvement associated with the complained event.Event date: unknown.Device is an instrument and is not implanted/explanted.(b)(6).The subject device has been received and is currently undergoing investigation.A device history record review was performed for complaint device lot number.Manufacturing location: (b)(4).Date of manufacture: feb 15, 2010.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the complaint device.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
(b)(6) reported the following event; there is a broken aiming arm for adolescent lateral entry femoral nail-ex from the adolescent lateral entry femoral nail-ex (alfn) set.No additional information was provided.Patient involvement is unknown.Update 27jan2017 - the aiming arm is missing a screw in the guide.The aiming arm was discovered broken at sterile processing.There was no patient involvement.This complaint involves one (1) device.
Additional Manufacturer Narrative
A product investigation was performed.The aiming arm for adolescent lateral femoral nail-ex (part # 03.010.227, lot number # 3319931) was returned and reported to be broken and to be missing a screw.This condition is confirmed; the knob of one of the proximal locking cams has broken off causing the locking cam to disassemble from the remainder of the device.A set screw was not returned.It is likely that over seven years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.However, this complaint is not likely a result of any design or manufacturing related deficiency.The device was manufactured in 2/2010 and is over seven years old.The balance of the returned device is in fairly worn condition with several markings along its length.A drawing was reviewed and it was determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.Upon review of the device history record, no ncrs germane to the complaint condition were generated during the production of this device.All measurements have been performed by calipers ca99p.A visual inspection, dhr review, and drawing review were performed as part of this investigation.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): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6348267
• Report Number: 3003875359-2017-10075
• Device Sequence Number: 977106
• Product Code: LXH
• UDI-Device Identifier: 10886982068095
• UDI-Public: (01)10886982068095(10)3319931
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2017

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: 03.010.227
• Device Lot Number: 3319931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 03/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1