MAUDE Adverse Event Report: SYNTHES HAGENDORF 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS; GUIDE

Catalog Number 357.366

Device Problems Fitting Problem (2183); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: no reported patient or surgical involvement.Although it is unknown when the devices became worn, the issue was discovered during inspection on (b)(6) 2016.Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) - manufacturing date: february 28, 2014.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 the product that would contribute to this complaint condition.Device 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 Description

It was reported that two (2) 130° aiming arms for use with the trochanteric fixation nail systems were found in a worn condition during a routine inspection of field equipment which was conducted on (b)(6) 2016.It was further noted that the 3.2mm guide wire would become stuck in the aiming arms and be difficult to remove.When used with different aiming arms, the wire functioned as intended; therefore, there is no allegation of malfunction against the wire.No reported patient or surgical involvement.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: a product investigation was completed: the device was slightly worn with scratches and marks on numerous locations.All of the identified damage was cosmetic and did not affect the functionality of the device.The device was tested/assembled with known conforming to test the locking mechanism of the aiming arm and no issues or discrepancies were detected.The aiming arm functioned as intended.Dimensional measurement of the device showed that it conformed to the design drawings.The design drawing for the device was reviewed and no drawing issues or discrepancies were noted.No manufacturing or design issues were noted during the investigation.The design is determined to be adequate for its intended use when used 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: 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS
• Type of Device: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5501492
• MDR Text Key: 40389530
• Report Number: 3003875359-2016-10181
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.366
• Device Lot Number: 8768155
• Other Device ID Number: (01)10886982196019(10)8768155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1