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

Model Number 314.743

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reportedly there was no patient involvement.Event date unknown.Device is an instrument and is not implanted/explanted.Additional classification code: hto.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history review: part number: 314.743.Synthes lot number: 7404017.Supplier lot number: n/a.Release to warehouse date: 12-dec-2013.Supplier: (b)(4).No nonconformances (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which 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.

Event Description

It was reported that the tip of the reamer shaft of the drive shaft-minimum 520mm length-for use with ria device is broken off.That small fragment is missing, and unable to be found.The instrument was found in central processing.There was no patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was performed.The complaint condition is confirmed as the drive shaft was received with a portion of the distal hex tip, which mates with the reamer head, broken.Five of the six walls that form the hex feature are missing, one wall does remain intact.The broken fragment was not returned.The break is located approximately 5.40mm from the distal tip.The helix is intact.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.No new malfunctions were identified as a result of the investigation.A visual inspection under 5x magnification, dimensional inspection, device history record (dhr) review and drawing review were performed at customer quality (cq) for the returned device as part of this investigation.No product design issues or discrepancies were observed.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Relevant drawings based on the date of manufacture were reviewed.The hexagonal tip (across flats) near location of breakage measured and is within specification per relevant drawing.The inner diameter was confirmed to be within the specification of per relevant drawing.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.There were no issues during the manufacture of this product that would contribute to this complaint condition.The design history was not found to impact the complaint condition.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: ACCESSORIES, ARTHROSCOPIC
• 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: 6898961
• MDR Text Key: 87879622
• Report Number: 1719045-2017-10989
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886982189042
• UDI-Public: (01)10886982189042(10)7404017
• 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: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• 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: 7404017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2013
• 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