MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RIA DRIVESHAFT L520; REAMER

Model Number 314.743

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 12/02/2017

Event Type  malfunction  

Manufacturer Narrative

No patient involvement reported.Additional device product code used: hrx.Device is an instrument and is not implanted / explanted.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.

Event Description

It was reported that the tip of a reamer-irrigator-aspirator (ria) shaft was found broken after sterile processing on (b)(6) 2017.The shaft was used during a lap bowel resection procedure at which the sales consultant was present on (b)(6) 2017 with no device issues noted.Sterile processing discovered the malfunction after the device went through sterile processing.The fragment tip is not available for return.There was no patient involvement.Concomitant device reported: reamer head (part# unknown, lot# unknown, quantity 1).This report is for one (1) drive shaft-minimum 520mm length for use with ria.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device history record review: part # 314.743 synthes lot number: 5282283.Supplier lot number: 14519-01 release to warehouse date: 13 jul 2006.Supplier: (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition a product development investigation was performed for the subject device (ria drive shaft, part number 314.743, lot number 5282283).The subject device was returned with the complaint condition stating a portion of the distal tip, which mates with the reamer head, broken off.The broken portion was not received.The roughly transverse break is located at the distal edge of the drive shaft helix.The helix is intact and shows scrapping along the outer surface.The proximal connecting post shows scraping and indents along the round position just distal to the transition to the flats.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.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The lot went through the required steps during the inspection at the time of manufacturing and the dhr records showed no issues concerning the material.Hardness was not reviewed as the flexible nitinol shaft does not have a hardness specification.Based on the date of manufacture/dhr the following drawings, 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 of 3.76mm +/-0.05 (3.71/3.81) per drawing at 3.73mm.The shaft directly proximal to the break could not be inspected due to the helix so the shaft on the proximal side of the helix was inspected and confirmed to be within the specification of 5.18mm +/- 0.025 (5.205/5.155) per drawing at 5.175mm.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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 as the circumstances at the time of the break are unknown.Concomitant device is retracted from the event.Lot and udi corrected.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

No concomitant device is associated with this event.

• Brand Name: RIA DRIVESHAFT L520
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7154485
• MDR Text Key: 96466673
• Report Number: 2939274-2017-50490
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982189042
• UDI-Public: (01)10886982189042(10)14519-01
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• 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: 5282283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2006
• 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