MAUDE Adverse Event Report: SYNTHES MONUMENT DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA; REAMER

Catalog Number 314.743

Device Problem Cut In Material (2454)

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

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

Patient initials ¿ (b)(6).Patient age and weight not available for reporting.Device is an instrument and is not implanted / explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review: 314.743 supplier lot#15022-01 / synthes lot#5602756.Release to warehouse date: 20sept2007.Supplier- (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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 a trochanteric fixation nail-advance (tfn-a) surgery, the drive shaft-minimum 520mm length-for use with reamer / irrigator/ aspirator tube was noted to be cut in half.The patient was undergoing a revision surgery on (b)(6) 2016 due to an infection.There was one (1) minute surgical delay reported.The surgeon used an alternate shaft to complete the surgery.There was not additional intervention needed.The procedure was successfully completed.(b)(4) is to report the malfunctioned device; the patient presenting an infection is reported under (b)(4).This is report 1 of 1 for (b)(4).

• Brand Name: DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5510911
• MDR Text Key: 40693620
• Report Number: 1719045-2016-10231
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042899
• 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
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.743
• Device Lot Number: 5602756
• Other Device ID Number: (01)10886982189042(10)5602756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2007
• 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