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

Catalog Number 314.743

Device Problems Break (1069); Mechanical Jam (2983)

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

Event Date 07/27/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Device is an instrument and is not implanted/explanted.A device history record review was performed for the complaint device lot: synthes lot number 5867802, supplier lot number 15687-01.Manufacturing location: synthes (b)(4), supplier: (b)(4).Manufacturing date/release to warehouse date: sep 19, 2008.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 complaint device.The complaint device has been received and is currently in the evaluation process.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 patient underwent revision surgery on (b)(6) 2016 due to nonunion after an ankle fusion procedure on an unknown date.During the revision surgery a reamer irrigator aspirator (ria) drive shaft and an unknown reamer head were used.While reaming, it was noted that the reamer was passing slowly; however, this was not unexpected.The following day, (b)(6) 2016, it was noted that the ria drive shaft was broken when it would not disengage from the reamer head.No fragments or broken pieces were generated.There was no negative impact to surgical procedure and no surgical time delay reported.The procedure was completed successfully.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: the drive shaft was received with the distal tip, which mates with the reamer head, broken off.The broken portion was not received.The balance of the device shows some surface wear but is in functional condition.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.One (1) reamer-irrigator-aspirator (ria) drive shaft l520 (part 314.743, lot 15687-01, mfg.19-sep-2008) was returned with a complaint stating that the distal end broke during a procedure.It was not noticed until the following day when the assembly could not be fully disassembled.The complaint condition is confirmed at customer quality as the drive shaft was received with the distal tip broken off.The broken portion was not received.Replication of the complaint is not applicable as the device was returned broken.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.Further evaluation at customer quality shows that, during use, the drive shaft is attached to the corresponding length reamer/irrigator/aspirator (ria) tube assembly and a reamer head and then connected to a drive unit.The ria system is intended for use to clear the medullary canal, to size the medullary canal, to harvest bone and bone marrow, and to remove infected and necrotic bone.The reamer/irrigator/aspirator (ria) addresses recommended use and information on care and maintenance is provided per the processing synthes reusable medical devices - instruments, instrument trays, and cases, the returned part was determined to be suitable for its intended use when employed and maintained as recommended.The complaint condition is the result of an overload of forces 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.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: 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; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5877687
• MDR Text Key: 52178859
• Report Number: 1719045-2016-10609
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• 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: 5867802
• Other Device ID Number: (01)10886982189042(10)5867802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2008
• 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
• Patient Weight: 91