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

Model Number 314.743

Device Problems Bent (1059); Break (1069)

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

Event Date 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Additional product code: hrx.Device is an instrument and is not implanted/explanted.Dhr review.Part # 314.743.Synthes lot # 5020042.Supplier lot # 13928-01.Release to warehouse date: 07 jun 2005.Supplier: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product, and any subcomponents, which would contribute to this complaint condition.Customer quality (cq) engineering investigation: visual inspection, device history record (dhr) review, dcrm review and drawing review were performed as part of this investigation.Visual inspection: at cq location, it was observed that the device distal tip is broken and missing a fragment approx.4 mm in length and in the shape of half of the circle.The shaft of the ria drive shaft is slightly bent.The broken fragment was not returned.The helix is intact but exhibits a cluster of indentation marks towards the distal end.The proximal connecting post shows excess wear which indicates that the user may have used excess force while attaching the drive shaft to the drive unit.Dhr review: review of the device history record showed that there were no issues with the material, hardness and during the manufacturing of this product and any subcomponents that would contribute to this complaint condition.Based on the date of manufacture/dhr the following drawings, reflecting the current and manufactured revision, were reviewed.Drive shaft assembly; drive shaft; ria (component): the across the flats distance at the hex tip measured in the range 4.36-4.38 mm per drawing.No drawing issues or discrepancies were noted.Dcrm review was performed due to broken instrument tip.This complaint condition is adequately covered by the risk assessment.The complaint condition is the result of force applied to the distal end of the drive shaft resulting in stresses beyond the failure limit of the shaft.The root cause could not be definitively determined.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 reamer/irrigator/aspirator (ria) shaft was bent and not performing properly during a revision of a distal tibia on (b)(6) 2017.The shaft was used to successfully complete the surgery with no delay and good patient outcome.Concomitant devices reported: reamer head (part number unknown, lot number unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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

Update: 12-11-17 - the revision was performed for removal of a competitor¿s product and a competitor¿s product was implanted during revision.

• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7101388
• MDR Text Key: 95735949
• Report Number: 1719045-2017-11208
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982189042
• UDI-Public: (01)10886982189042(10)13928-01
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042899
• 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: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 314.743
• Device Catalogue Number: 314.743
• Device Lot Number: 13928-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2005
• 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