MAUDE Adverse Event Report: SYNTHES MONUMENT 12.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

Catalog Number 352.251S

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 09/25/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Device is an instrument and is not implanted/explanted.The subject device was discarded by the reporting facility.(b)(4) unanticipated intraoperative x-rays.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 on (b)(6) 2015, during a tibial nail exchange procedure, while reaming the femur for a graft using the reamer irrigator aspirator (ria) system, the reamer head disengaged and the drive shaft tip shattered and fragmented.The metal shards in the patient were successfully removed; additional x-rays were taken to ensure the fragments were removed.Another drive shaft was available for use; it was brought in from another facility and "flashed." the tibial nail was removed with a ball tip guide rod and implanted the new nail.The procedure was completed successfully without further incident.Patient was reported as stable.No surgical delay was reported.The need for revision surgery is addressed and reported under related complaint (b)(4).This report addresses the events involving the ria system during the surgery.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Additional patient information: patient height reported as 173cm.Device 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

Update: it was further reported that the base and the head of the device shattered.All fragments were retrieved and ultimately discarded.

Manufacturer Narrative

Device 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

Update: per updated information received on november 3, 2015, the patient reportedly returned to the doctor regarding a large callous found on the lateral side of the tibia.An x-ray image showed part of the reamer head was embedded inside the patient, which had not been seen during the initial procedure.The patient was overall happy with the healing process and the outcome of the surgery.The patient and the surgeon agreed to leave the piece/fragment in situ as the patient was not experiencing any symptoms or discomfort.

• Brand Name: 12.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
• 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: 5135798
• MDR Text Key: 27770567
• Report Number: 1719045-2015-10658
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Catalogue Number: 352.251S
• Device Lot Number: 6048827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2008
• 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 Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 80