MAUDE Adverse Event Report: SYNTHES MONUMENT DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA; REAMER

Catalog Number 314.742

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

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

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.(b)(6).The subject device has been received and is currently undergoing investigation.The results are pending completion.A device history record review has been requested, the results are pending completion.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reported an event in (b)(6) as follows: it was reported that during a revision surgery due to a chronic knee infection not related to synthes devices, the end of the reamer/irrigator/aspirator drive shaft broke interoperatively.No fragments were retained in the patient.There was no reported patient harm due to the event.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part # 314.742, lot # 7081940.Release to warehouse date: (b)(6) 2013, supplier: (b)(6).No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the 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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The manufacturing evaluation results are as follows.The evaluation has shows that the hexagon is broken off at the crossover to the shaft.The manufacturing documents were reviewed and no complaint related issues were found.This device was manufactured in may 2013 according to the specification.The relevant dimensions were checked and no deviation from the specification could be detected.The fracture face is homogenous, which indicates material conformity.These findings speak against a manufacturing related issue.Based on the provided information, it is unknown where, when or how the breakage occurred, we are not able to determine the root cause.We can only assume that a mechanical overload did lead to this malfunction 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 360MM 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: mark vornheder ; 1302 wrights lane east; synthes usa; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6064386
• MDR Text Key: 58719046
• Report Number: 1719045-2016-10793
• Device Sequence Number: 1
• Product Code: HTO
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.742
• Device Lot Number: 7081940
• Other Device ID Number: (01)07611819739192(10)7081940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2013
• 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