MAUDE Adverse Event Report: SYNTHES HAGENDORF 130 DEG AIMING ARM; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 03.037.013

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

It was reported that during implantation of the helical blade and nail construct there were issues with guide sleeve.During insertion of the helical blade, the helical blade slid and back-out halfway from the guide sleeve but then was reinserted successfully.After the surgeon inserted the helical blade into the nail with the guide sleeve was difficult to disengage because it was sticking in the compression nut and the aiming arm.There was a one minute surgical delay due to the reported event.The surgery was successfully completed without additional medical intervention without patient harm.The patient's postsurgical outcome was reportedly good.Concomitant devices reported: nail (part 04.037.042s, lot unknown, quantity 1); helical blade (part 04.038.300s, lot unknown, quantity 1); helical blade inserter (part unknown, lot unknown, quantity 1).This is report 2 of 2 for com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (130 deg aiming arm, part number 03.037.013, lot number 9460289).The subject device was returned with the complaint condition stating that a blade/screw guide sleeve (03.037.017, lot 9704087) was sticking while assembling with a 130 degree aiming arm (03.037.013, lot 9460289) which resulted in a one minute surgical delay; no reported patient harm.The returned devices are part of the trochanteric fixation nail advanced (tfna) system.The blade/screw guide sleeve is connected to the aiming arm (03.037.013) via the locking clip (03.037.015) and the buttress compression nut (03.037.016).This provides a cannula to target the oblique hole of the tfna nail.This information is provided per the tfna technique guide.The relevant drawing for the returned device was reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of this device.A device history record review was performed for the subject device lot number 9460289.Manufacturing location: (b)(6).Date of manufacture: jun 2, 2015.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 subject device.The returned devices were examined and no identifiable defects or deficiencies were noted which could have potentially contributed to the reported complaint condition.The instruments were able to be assembled and interacted as intended.As the complaint condition as unable to be replicated and no identifiable defects or deficiencies were noted, the complaint is unconfirmed.No root cause was able to be determined as the complaint condition was unable to be replicated.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
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf PA CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6025760
• MDR Text Key: 57333146
• Report Number: 2520274-2016-14895
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.013
• Device Lot Number: 9460289
• Other Device ID Number: (01)10886982070296(10)9460289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/23/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2015
• 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
• Treatment: HELICAL BLADE (04.038.300S); NAIL (04.037.042S); UNKNOWN HELICAL BLADE INSERTER
• Patient Age: 76 YR