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

Model Number 03.037.013

Device Problem Mechanical Jam (2983)

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

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Patient¿s gender and weight are not available for reporting.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.A device history record (dhr) review was performed for part #: 03.037.013, lot #: 9621604: manufacturing location: (b)(4), manufacturing date: 30.Sep.2015: no non-conformance reports (ncrs) 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.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 the blade guide sleeve became lodged in the 130-degree aiming arm and could not be removed during a trochanteric fixation nail-advanced proximal femoral nailing system (tfna) intramedullary (im) femoral nail insertion on (b)(6) 2017.The guide wire was inserted and the surgeon wanted to reposition the guide wire and attempted to withdraw the blade guide sleeve; however, the sleeve would not withdraw.The surgeon attempted to remove it by pressing the button and sliding it back, but that would not work.The surgeon tried to turn the buttress nut clockwise to remove it, but that would not work either.The surgeon had to disassemble the aiming arm and use another aiming arm and blade guide sleeve assembly from another set at the hospital.There was about a ten (10) minute surgical delay while attempting to remove the sleeve and obtain another set.The surgery was successfully completed with no adverse effect on the patient.There is no additional information.Concomitant devices reported: 3.2 mm wire guide sleeve (part #: 03.037.018, lot #: 9919792, quantity: 1), 3.2 mm trocar (part #: 03.037.019, lot #: 9942803, quantity: 1), aiming arm locking device (part #: 03.037.015, lot #: 960542, quantity: 1), unknown guide wire (part #: unknown, unknown lot number, quantity: 1).This report is for one (1) 130 degree aiming arm.This is report 1 of 2 for complaint com-(b)(4).

Manufacturer Narrative

A product development investigation was performed.Customer quality (cq) engineering investigation: a visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed at cq for the returned devices as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.The post manufacturing damage to the blade guide sleeve now prevents the buttress nut from threading fully onto the blade guide sleeve.The complaint condition was able to be replicated at cq.A functional test at cq confirmed that post manufacturing damage to the blade guide sleeve now prevents the buttress nut from threading fully onto the blade guide sleeve.Because the two cannot be fully assembled, they cannot be inserted into the aiming arm so this complaint condition could not be confirmed.The blade guide sleeve did fit inside the aiming arm when tested without the buttress nut.No new malfunctions were identified as a result of the investigation.The following concomitant parts were returned without an allegation against them: part #: 03.037.018, lot #: 9919793, quantity: 1, part #: 03.037.019, lot #: 9942803, quantity: 1.Upon inspection at cq, there is no evidence that suggests that these concomitant devices may have caused or contributed to the reported complaint condition, and therefore no further investigation will be performed on these concomitant devices.The major thread diameter of blade/screw guide sleeve was measured and found to be within specification per relevant drawing.However, post manufacturing thread damage was observed on the distal section but it is unknown if this was prior to the complaint occurred or a result of forcefully separating the instruments.Visual inspection revealed no damage or wear to the aiming arm and buttress nut.A dimensional inspection of features related to this complaint on the aiming arm was not performed during this investigation because the blade guide sleeve was able to fit inside the aiming arm.The core diameter of buttress/compression nut (major thread to major thread) was measured and found to be within per relevant drawing.Relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.The material was determined to be conforming at the time of manufacture based on review of the dhr.Unable to determine a definitive root cause.No new, unique or different patient harms were identified as a result of this evaluation.The returned parts were determined to be suitable for the intended use when employed 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.

Manufacturer Narrative

Date returned to manufacturer.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 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
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6843617
• MDR Text Key: 86576029
• Report Number: 3003875359-2017-10441
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070296
• UDI-Public: (01)10886982070296(10)9621604
• 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,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.013
• Device Catalogue Number: 03.037.013
• Device Lot Number: 9621604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• 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
• Patient Age: 16 YR