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

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight not provided by reporter.(b)(4).Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Subject device has not been received.Without a lot number, the device history record review and 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 an ankle fixation revision the 12.0mm reamer head-sterile for reamer/irrigator/aspirator (ria) and the drive shaft-minimum 360mm length-for use with ria broke off.The surgeon was able to remove most of the parts, however five (5) un-distinguishable fragments were left inside canal of the femur, x-rays confirmed the fragments.Despite the device malfunction, the surgeon determined he had enough of the aspirated material for the bone graft and completed the surgery successfully.There was a 10 min delay.Patient outcome was successful.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

A device history record review was performed for the subject device lot 5672721, supplier lot number (b)(4).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 subject device was supplied by (b)(4)., and repackaged by (b)(4).The release to warehouse date is jan 7, 2008.The subject device has been received and is currently in the evaluation process.Correct lot number was identified upon receipt of the subject device and reported.Udi# corrected.Supplier lot number is (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).Product investigation summary: one drive shaft minimum 520mm length (part 314.743 / lot number 5672721) and one 12.0mm reamer head, sterile (part 352.250s / lot 9842322) were received with the complaint category of ¿broken: intraoperatively.¿ the complaint condition is confirmed as the drive shaft was received with the distal tip broken off.The break is roughly transverse and located within 10mm to 14mm from the distal edge of the drive shaft helix.The helix is significantly scraped and worn down.The reamer head was received with all four proximal prongs broken off at the base.The broken portions were not received.The root cause could not be definitively determined as the circumstances at the time of the break are unknown.Per the technique guide a cannulated drive unit that delivers only 3.5-4.5nm of torque and 700-900 rpm is to be used.The technique guide also cautions that no reduction drive units or drills with a torque greater than 6nm should be used.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.The device history record reviews found a release date of january, 2008 for the drive shaft and august, 2015 for the reamer head.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of these products that would contribute to this complaint condition.Further evaluation shows that, during use, the drive shaft is attached to the corresponding length 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.A review of the current design drawings for the top level assembly, the drive shaft component, and the reamer head was performed.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for their 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.The root cause could not be definitively determined as the circumstances at the time of the break are unknown.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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.

• 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: 5441212
• MDR Text Key: 38330217
• Report Number: 2520274-2016-11085
• 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: Initial,Followup,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• 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: 5672721
• Other Device ID Number: (01)10886982189042(10)5672721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2008
• 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: 68 YR