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

Model Number 314.743

Device Problem Break (1069)

Patient Problem Death (1802)

Event Date 09/12/2017

Event Type  Death  

Manufacturer Narrative

Additional product code: hrx.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Customer quality medical safety officers assessed the event.The complainant reported that the drive shaft-minimum 520mm length-for use with ria broke at the tip.There were no fragments left in the patient, all pieces were retrieved and despite the broken shaft, the surgery was completed successfully.There was no surgical delay, no additional x-rays or medical interventions needed.Upon completion of the surgery, the patient coded on the table and was pronounced dead approximately 15 minutes later.It was reported that the patient had numerous comorbidities, including kidney failure and was "very sick".Furthermore there was insufficient time for fat embolism to occur and it was confirmed that the femoral canal was not breached, which could lead to intraoperative death due to rapid blood loss.In conclusion, the breakage of the ria shaft would not have contributed to the death.Dhr review for part # 314.743 lot # 15803-01, release to warehouse date: 09 may 2011, expiration date: na, supplier: (b)(6).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

Event Description

It was reported that during a revision reamer/irrigator/aspirator (ria) bone graft harvesting on (b)(6) 2017, the drive shaft-minimum 520mm length-for use with ria broke at the tip.The original surgery for a hip repair was performed with stryker devices on unknown date.The patient fell post-op and required the stryker device to be revised to a total hip replacement.During the revision of the stryker device the ria drive shaft broke.There were no fragments left in the patient and despite the broken shaft, the surgery was completed successfully.There was no surgical delay, no additional x-rays or medical interventions needed.Upon completion of the surgery, the patient coded on the table and had to be stitched up right away.The patient was rushed to the emergency room (er) where the patient was pronounced dead approximately 15 minutes later.Concomitant devices reported: reamer head: ( part number unknown, lot number unknown, quantity 1), medullary nails: (part number unknown, lot number unknown, quantity unknown).This report is for one (1) drive shaft for use with (b)(6).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The device was received and the product evaluation is in progress.No conclusion can be drawn.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.

Manufacturer Narrative

A product investigation was performed.Mso review concluded that this death resulted due to patient numerous comorbidities.Furthermore this death was independent and unrelated to the use of our product, the ria.There was insufficient time for fat embolism to occur and the femoral canal was not breached, which could lead to intraoperative death due to rapid loss.Finally the breakage of the ria shaft would not have contributed to the death and the pieces were retrieved.The complaint condition is confirmed as the drive shaft was received with the distal tip, which mates with the reamer head, broken.The broken fragment was not returned.The roughly spiral break is located within approximately 8.5mm to 10.6mm distal to the distal edge of the drive shaft helix.The helix is intact.The proximal connecting post shows wear along the groove consistent with use.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.No additional malfunctions were observed during investigation.Relevant drawings based on the date of manufacture/dhr, reflecting the current and manufactured revision, were reviewed.Due to the damage at the fracture and missing portion applicable measurements of the hexagonal tip could not be obtained.The inner diameter was confirmed to be within the specification per relevant drawing.The shaft directly proximal to the break, was confirmed to be within the specification per relevant drawing.The complaint condition is the result of force applied 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.There were no issues during the manufacture of this product that would contribute to this complaint condition.The design history was not found to impact the complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: 6880882
• MDR Text Key: 86829771
• Report Number: 1719045-2017-10960
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982189042
• UDI-Public: (01)10886982189042(10)15803-1
• 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,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 314.743
• Device Catalogue Number: 314.743
• Device Lot Number: 15803-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2011
• 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): Death
• Patient Age: 79 YR