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 Code Available (3191)

Event Date 09/25/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient initials (b)(6).Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the manufacturer for evaluation.(b)(4).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 1 of 2 for (b)(4).

Manufacturer Narrative

Product investigation summary: one drive shaft, minimum 520mm length, for use with reamer/irrigator/aspirator (ria) (part 314.743 / synthes lot 5236556 / supplier lot 14382-01) was received with the complaint category of ¿broken: intraoperatively.¿ the complaint condition is confirmed for the drive shaft as it was received with the distal tip broken off.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.Specific details regarding the technique used/handling which led to the device failure were not provided.However, it is most probable that excessive force and/or use of an incorrect drive unit repeatedly over torqued the drive shaft leading to fatigue and ultimately the fracture at the distal tip.Further evaluation 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 returned drive shaft was received with the distal tip, which mates with the reamer head, broken off.The break is roughly spiral and located within 6.0mm to 20.8mm of the distal edge of the drive shaft helix.The helix is worn, but intact and the broken tip was not received.The missing portion is estimated to be a maximum of 15.5mm long, but was reported to have fragmented so is likely in smaller pieces.The proximal connecting post shows significant scraping and wear.The balance of the device shows surface scratches and is in working condition.Thus, the complaint condition is confirmed and consistent with the reported condition, but cannot be replicated as the shaft is already broken.A review of the current design drawing/manufactured revision was performed.The design history was found to not impact the complaint condition.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.Specific details regarding the technique used/handling, which led to the device failure were not provided; however, it is most probable that excessive force and/or use of an incorrect drive unit repeatedly over torqued the drive shaft leading to fatigue and ultimately the fracture at the distal tip.The condition of the returned drive shaft is consistent with damage caused by the device being repeatedly over torqued and/or having been subjected to excessive force.It is critical for the reliable function of the drive shaft that a cannulated drive unit that delivers only 3.5-4.5nm of torque and 700-900rpm be used.The technique guide states that no reduction drive or drills with a torque greater than 6nm be used.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.

Manufacturer Narrative

Additional patient information: patient height reported as 173cm.Associated synthes lot 5236556.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.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.

• 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: 5136847
• MDR Text Key: 27805365
• Report Number: 1719045-2015-10657
• 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,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 Catalogue Number: 314.743
• Device Lot Number: 14382-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2006
• 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