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

Model Number 314.743

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

Additional product code: hrx.Dhr review for part # 314.743 lot # 15803-01.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 that would contribute to this complaint condition.Release to warehouse date: 09 may 2011, supplier: (b)(4).The drive shaft was received with a portion of the distal tip, which mates with the reamer head, broken off.The broken portion was not received.The break is over approximately half of the circumference and extends from the distal edge to a furthest point 6.5mm from the distal edge.The helix is intact and shows scraping along the outer surface.The proximal connecting post shows wear along the groove consistent with use.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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.No ncr's were generated during production.Based on the date of manufacture/dhr the drawings, reflecting the current and manufactured revision, were reviewed.A dcrm review and/or occurrence rate calculation must be performed for all complaint parts which resulted in a classification of serious injury that were not generated from a literature article.Therefore, no dcrm calculation will be performed for this complaint.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 as the circumstances at the time of the break are unknown.The state of the drive shaft from its 5 year lifespan and thus at the initial difficult assembly it unknown.The reamer/irrigator/aspirator (ria) technique guide addresses recommended use information on care and maintenance is provided per the processing synthes reusable medical devices ¿ instruments, instrument trays, and cases.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 retrograde nail case the tip of the reamer/irrigator/aspirator (ria) drive shaft broke off.During the procedure it was noticed that assembly of the shaft being placed through the shaft sleeve and into the reamer head was difficult.It was further reported that the shaft did not fit all the way in place, but they were still able to use the device to complete the procedure.After the procedure it was noticed that the shaft was missing the tip.The fragment was located and discarded by the facility.There was no delay in surgery and no report of patient harm.Concomitant devices reported: shaft sleeve (part number unknown, lot number unknown, quantity 1) reamer head (part number unknown, lot number unknown, quantity 1).This report is for one (1) drive shaft for use with ria.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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6710718
• MDR Text Key: 80134771
• Report Number: 1719045-2017-10649
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982189042
• UDI-Public: (01)10886982189042(10)15803-01
• 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
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• 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: 15803-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2011
• 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