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

Catalog Number 314.743

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

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

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight is not available for reporting.Implant and explant date: device is an instrument and is not implanted/explanted.The subject device expected to be returned to the synthes manufacturer for evaluation but has not yet been received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot.Manufacturer: (b)(4).Date of manufacture: may 5, 2011.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.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 graft harvesting procedure on (b)(6) 2016 with the reamer-irrigator-aspirator (ria) system three devices broke, a drive shaft for ria, a 12.5mm reamer head, and a 13.5mm reamer head.Fragments were generated but were easily removed.The procedure was completed with back up devices.There was a ten (10) minute surgical delay due to the reported event.The patient is reportedly stable.The procedure was successfully completed.Concomitant device reported: locking clip for ria, sterile (part # 352.260s, lot # unknown, qty 1).This report is 1 of 3 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 development investigation is performed.The returned drive shaft (314.743, 15808-01) and 12mm/12.5mm/13mm reamer heads ((352.250, 7586107) (352.251, 6408211) (352.252, 6632613)) are part of the reamer/irrigator/aspirator (ria) system used for intramedullary reaming and bone harvesting.The returned drive shaft was received with the distal tip which mates with the reamer head broken off.A portion of the broken off piece was also received and measured to be approximately 13.29mm.The returned 12.0mm and 13.0mm reamer heads ((352.250, 7586107) (352.252, 6632613)) were received with their fingers which are intended to mate with the distal tip of drive shafts broken off.The 12.5mm reamer head (352.251, 6408211) was received with its fingers bent inwards.After inspection of the returned parts the complaint condition of broken was confirmed for the drive shaft and 12mm/13mm reamer heads, however the 12.5mm reamer head only had inwardly bent fingers.Replication of the complaint condition is not applicable for the returned parts, considering their condition, however the complaint condition will be considered confirmed.As part of this investigation a visual inspection and drawing review were performed.All relevant drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.Based on the available information it is not possible to determine a definitive root cause for the complaint conditions.It is possible that exposure to excessive forces due to the use of an incorrect drill could have contributed to the complaint condition of broken.The ria technique guide states that a cannulated drive unit that will deliver 3.5nm to 4.5nm of torque and 700 rpm to 900 rpm (standard drill speed) must be used.It is specifically noted not to use a reductive drive, drills with a torque greater than 6nm, or power equipment designed for reaming.The complaint condition of inwardly bent reamer head fingers most likely occurred due to rough handling during use and or processing.During the investigation no unidentified 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.

Event Description

It was reported that two additional reamer heads became damaged when the ria was being disassembled following the surgery.This is report 1 of 4 for (b)(4).

• Brand Name: DRIVE SHAFT-MINIMUM 520MMLENGTH-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: 6244449
• MDR Text Key: 64606128
• Report Number: 1719045-2017-10015
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982189042
• UDI-Public: (01)10886982189042(10)15808-01
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.743
• Device Lot Number: 15808-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2011
• 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
• Treatment: 352.260S, LOCKING CLIP-STERILE FOR RIA, QTY 1
• Patient Age: 32 YR