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

Catalog Number 314.743

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Inadequate Osseointegration (2646); Device Embedded In Tissue or Plaque (3165)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient initials are (b)(6).(b)(4).Device is an instrument and is not implanted/explanted.Device history records was conducted.The report indicates that the: dhr review, part number: 314.743, lot number: 6921238, release to warehouse date: october 3, 2012, 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.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 patient underwent revision of a trochanteric fixation nail (tfn) of the right hip due to non-union.Date of initial implant is unknown.During revision surgery, a femoral osteotomy with retrograde nail insertion, while reaming the femur, the tip of a drive shaft broke off and remained retained in the femur.Procedure was completed successfully.There was no delay.This complaint involves one device (reamer).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

A product investigation was completed: per technique guide, the drive shaft is attached to the corresponding length reamer/irrigator/aspirator (ria) tube assembly and a reamer head and then connected to a drive unit.The ria system is intended for use to clear the medullary canal, to size the medullary canal, to harvest bone and bone marrow, and to remove infected and necrotic bone.The returned drive shaft was received with a portion of the distal tip, which mates with the reamer head, broken off.The break is roughly spiral and located within 7mm of the distal edge of the drive shaft helix to the end of the device (21.5mm).The helix is intact and the broken portion was not received.The missing portion is estimated to be a maximum of 14.5mm long based on drawing.The proximal connecting post shows four indents along the groove.The balance of the device shows some surface scratches/nicks and is in working condition.Thus, the complaint condition is confirmed and consistent with the reported condition but cannot be replicated as the shaft is already broken.A review of the current design drawing/manufactured revision was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The condition of the returned drive shaft is consistent with damage caused by the device being repeatedly over torqued and/or having been subjected to excessive force.It is critical for the reliable function of the drive shaft that a cannulated drive unit that delivers only 3.5-4.5nm of torque and 700-900rpm be used.The technique guide states that no reduction drive or drills with a torque greater than 6nm be used.Specific details regarding the technique used/handling which led to the device failure were not provided, however it is most probable that excessive force and/or use of an incorrect drive unit repeatedly over torqued the drive shaft over the three (3) year lifespan leading to fatigue and ultimately the fracture at the distal tip.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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.

• 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: 5227140
• MDR Text Key: 31357797
• Report Number: 1719045-2015-10738
• 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,Followup,Followup
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.743
• Device Lot Number: 6921238
• Other Device ID Number: (01)10886982189042(10)6921238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/18/2015; 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR