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

Model Number 314.743

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2017

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: hrx.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for # 314.743, lot # 7353283: release to warehouse date: dec 13, 2013, expiration date: na, supplier: (b)(6).: no non conformance reports (ncrs) 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.The device has been 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.

Event Description

It was reported that a distal tip of the reamer/irrigator/aspirator (ria) drive shaft broke off during a left tibia fracture repair procedure on (b)(6) 2017.As the surgeon was reaming to obtain bone graft from the right tibia, midway through reaming the locking clip on the ria assembly popped off (this is thought to have contributed to the ria shaft becoming damaged).When the surgeon pulled the assembly out, it was identified that the tip of the reamer shaft had been cut up and damaged.At that point, the surgeon decided that enough bone graft had been obtained.There were fragments created, which were confirmed via x-ray to have been retrieved.There was a reported surgical delay of fifteen (15) minutes due to getting the assembly pulled apart and assessing it for continued use and cleaning out the fragments.A nail, locking screws and bone graft were used to repair the left tibia fracture.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: reaming rod (part # 351.706s, lot # h297378, quantity 1); tube assembly (part # 314.746s, lot # h252074, quantity 1); drive shaft seal (part # 351.718s, lot # h370658, quantity 1); reamer head (part # 352.254s, lot # h119001, quantity 1).This report is for one (1) drive shaft.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Following device was returned for cq investigation; drive shaft-minimum 520mm length-for use with ria part #314.743, synthes lot# 7353283 the returned instrument was examined at customer quality and the complaint condition was able to be confirmed.A visual inspection, device history records review, drawing review and dimensional verification of the relevant device features were performed as part of this investigation.A functional test or complaint replication is not applicable as the damage was visually confirmed.No new malfunctions were identified during the investigation.Drive shaft for use with ria (part #314.743) is used under the intramedullary reaming and bone harvesting.It is implemented for autogenous bone harvesting and removing infected and necrotic bone and tissue from the intramedullary canal.The ria drive shaft (part #314.743, lot # 7353283) was returned with the tip missing leaving the distal instrument shaft in the jagged form.The helix of the shaft is intact.The broken fragment was not returned with the complaint.There are superficial striation marks over the surface of the shaft, which does not impact functionality.Dhr review for part # 314.743, lot # 7353283.Release to warehouse date: 13 dec 2013.Supplier: (b)(4).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.Relevant product drawings were reviewed: drive shaft assembly drawing and drive shaft helix.Od of the distal tip could not be measured due to missing fragment.Portion of the distal tip, approx.14.5 mm in length, is missing.Hence od of the helix feature which is within a close proximity of the broken tip was measured.Od of the helix was measured within the specification at 6.04 mm (spec: 6 mm +/-0.1).The design, materials and finishing processes were found to be appropriate for the intended use of these devices.It is possible that the tip of the ria reamer shaft was damaged due to excessive torque or off-axis force applied on the device.As the complaint mentions, locking clip on the ria assembly popped off during operation.Locking clip does not interfere with the function of the reaming rod hence there is a minute chance that this condition would 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: 6688990
• MDR Text Key: 79137780
• Report Number: 1719045-2017-10629
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982189042
• UDI-Public: (01)10886982189042(10)7353283
• 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
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 314.743
• Device Catalogue Number: 314.743
• Device Lot Number: 7353283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2013
• 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: DRIVE SHAFT SEAL (PART 351.718S, LOT H370658, QTY; REAMER HEAD (PART 352.254S, LOT H119001, QTY 1); REAMING ROD (PART 351.706S, LOT H297378, QTY 1); TUBE ASSEMBLY (PART 314.746S LOT H252074, QTY 1 )
• Patient Age: 51 YR