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 Device Embedded In Tissue or Plaque (3165)

Event Date 01/20/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.Additional facility contact is prof.(b)(6).Reporting facility phone number is (b)(6).The subject device has been received and is currently undergoing investigation; the results are pending completion.A device history record review for the subject device lot has been requested.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 europe reported an event in the (b)(6) as follows: it was reported that during reaming with the reamer-irrigator-aspirator (ria) the connection between the ria drive shaft and the ria medullary reamer head had been destroyed.A lot of fragments were generated.All broken off pieces could be removed from the patient except one was not found.It is not known if this broken off piece was left in the patient or not.The surgery was prolonged approximately 30 minutes due to the reported event.Concomitant reported part: 1x ria tube assembly (part and lot unknown).This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Additional product code: hrx.Release to warehouse date: august 19, 2013.Supplier: (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.A product investigation was completed: the overall complaint condition is confirmed as the reamer head was received with three of the four proximal prongs broken off and the ria drive shaft was received with the distal tip broken off.All broken off parts were returned for investigation.The review of the production histories revealed that both instruments were manufactured according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.Unfortunately the exact cause of failure cannot be determined; however the failure mode is consistent with a mechanical overloading.Although the exact cause cannot be determined, this complaint condition is likely a result of a mechanical overload; the complaint is determined not to be a result of a detected product related deficiency.No product related issues were found.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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6332844
• MDR Text Key: 67508481
• Report Number: 1719045-2017-10111
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819739208
• UDI-Public: (01)07611819739208(10)7312608
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.743
• Device Lot Number: 7312608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2013
• 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
• Treatment: UNKNOWN RIA TUBE ASSEMBLY, QTY 1
• Patient Outcome(s): Required Intervention