MAUDE Adverse Event Report: SYNTHES HAGENDORF PERCUTANEOUS RADIOLUCENT INSERTION HANDLE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 03.037.112

Device Problem Fitting Problem (2183)

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

Event Date 11/09/2016

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.(b)(4).Device is an instrument and is not implanted/explanted.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.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 a cannulated connecting screw became stuck in a trochanteric fixation nail advanced (tfna) and an insertion handle could not be removed during a left intertrochanteric fracture repair on (b)(6) 2016.There was a reported fifteen (15) minute surgical delay.The procedure was completed successfully with the patient in stable condition.This complaint involves two devices concomitant devices reported: tfna (part #04.037.245s, lot #h146700, quantity 1).This report is 2 of 2 for (b)(4).

Manufacturer Narrative

(b)(4).Device history record review: manufacturing location: (b)(4); manufacturing date: 22.Oct.2015.No 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 manufacturer investigation results are as follows.The returned insertion handle is in good condition with no issues noted.The concomitant nail was not returned, therefore the interaction between the 3 parts was unable to be tested.No 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.A visual inspection, drawing review and dhr review were performed as part of this investigation.Usage of the returned devices is outlined in the tfna proximal femoral nailing system technique guide (dsus/trm/0614/0109(2).No definitive root cause was able to be determined, as the concomitant nail was not returned and was unable to be tested with the returned parts.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: PERCUTANEOUS RADIOLUCENT INSERTION HANDLE
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6145798
• MDR Text Key: 61497959
• Report Number: 2520274-2016-15585
• 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: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.112
• Device Lot Number: 9607179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• 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: 04.037.245S, LOT #H146700, QUANTITY 1)