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

Catalog Number 314.743

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2015

Event Type  malfunction  

Event Description

It was reported that, while performing a reamer irrigator aspiration (ria) for a bone graft, the drive shaft assembly came apart.It is suspected that the drive shaft was defective.The surgeon completed the procedure with a different drive shaft.No patient harm was reported.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Patient identifying information is not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but it has not been received as of yet.The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: lot 5846620 (supplier lot# 15686-01); criterion tool & die, inc.Manufactured the drive shaft assembly for ria, part #314.743, and lot 5846620 (supplier lot 15686-01), delivered august 4, 2008.Initially, the parts conformed to the supplier¿s certificate of conformance, dated july 29, 2008, and synthes final inspection sheet.The parts were released to the warehouse on august 14, 2008.There were no material review reports, non-conformance reports, or complaint related issues with this lot.Device 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

Device was returned to manufacturer for review/investigation on january 26, 2015.Subject device has been received.The investigation could not be completed; no conclusion could be drawn as the product is entering the complaint system.Device 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

There was a reported 10 minute surgical delay due to the reported event.

Manufacturer Narrative

A product development evaluation was completed: one ria driveshaft (314.743) was returned.It shows signs of light use but is otherwise in good condition.When tested the driveshaft was able to be connected to a tube assembly (314.746s) with no issues.The ria system is intended to clear the medullary canal of bone marrow and debris, size the medullary canal for implants or prosthesis, and to harvest bone and bone marrow in the treatment of osteomyelitis.To use the system the driveshaft (314.743) must be connected to a single use tube assembly (314.746s).The complaint condition for this part is that it came apart.Further discussion revealed that specifically the driveshaft and the tube assembly could not be connected.The returned driveshaft is in good condition and shows signs of light use.When tested the complaint condition could not be duplicated; the driveshaft was able to connect to a tube assembly with no issue.This, along with the fact that the driveshaft was manufactured in 2008 and had been used before suggest that the source of the problem was most likely the tube assembly.The tube assembly was not returned, so further investigation into the cause of the complaint is not possible.Drawings for the driveshaft and the tube assembly were reviewed and determined to be suitable for the intended design and application.After reviewing the related product drawings, complaint history and risk analysis, the design is adequate for its intended use and did not contribute to this complaint condition.The driveshaft that was returned is in good condition and the complaint could not be duplicated therefore this complaint is unconfirmed.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 the procedure was completed successfully.It was also reported there was a ten minute delay in the procedure.

• 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: 4430476
• MDR Text Key: 5374678
• Report Number: 1719045-2015-10048
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 15686-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2015
• Initial Date FDA Received: 01/19/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/05/2015; 03/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2008
• 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