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

Catalog Number 314.743

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 routine inspection of synthes field equipment, it was discovered that the tip of the reamer irrigator aspirator was broken off.There was no procedure or patient involvement.The tip was not found.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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.A product investigation was completed: the drive shaft was received with a portion of the distal tip, which mates with the reamer head, broken off.The roughly oblique break is located between 7.3mm proximal to 11.5mm distal of the distal edge of the drive shaft helix with a small portion bent and extending to 13.2mm from the distal edge of the drive shaft helix.The helix is intact and the broken distal portion was not received.The proximal coupling post shows dents and worn edges.The balance of the device is in working condition.Specific details regarding the technique used/handling is unknown; however, it is most probable that excessive force and/or use of an incorrect drive unit repeatedly over torquing the drive shaft over the devices approximately 10 year lifespan resulted in fatigue and that applied force thereafter likely permitted final separation of the distal tip.A review of the current design drawing and the drive shaft component was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.(b)(4).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: 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: 5380297
• MDR Text Key: 36480628
• Report Number: 1719045-2016-10083
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• 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: 14082-01-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2005
• 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