MAUDE Adverse Event Report: SYNTHES MONUMENT SAW 20.1X21.4X4.0X0.6MM FOR PIEZOELECTRIC SYSTEM-STER; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACHMENT

Catalog Number 03.000.402.98S

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

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

Event Date 09/02/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional device product codes are: erl, hbe, and hwe.(b)(4).Device is an instrument and is not implanted/explanted.The subject device has been received and in undergoing investigation.The investigation results are pending completion.A device history records review has been requested.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 craniectomy procedure on (b)(6) 2016, one tooth of the saw blade broke off while cutting bone.The broken piece was retrieved via suction.There was a one minute surgical delay was due to exchanging the broken blade for a new one.There was no patient harm and the procedure was completed successfully.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(4).Manufacturing date: june 10, 2016.Shelf life expiry date: may 01, 2021.Manufacturing location: supplier ((b)(4)).Business group: (b)(4).Device 03.000.402s is a batch number controlled product, therefore no service history record review is possible.No non-conformance reports 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 conclusion of the device history record(s) review is that the final products manufactured in the production processes relevant to the device in the current complaint met inspection requirements, certification test values, and acceptance criteria.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

Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the saw (brand name saw 20.1x21.4x4.0x0.6mm for piezoelectric system-ster, part number (03.000.402.98s, lot number 603024/1).The subject device was returned to the manufacturer with the complaint condition stating the device was received with the tooth broken off.After observations, dimensions of the tip are conformed to its definition,expect the broken teeth remarkable at first sight.Visual aspect looks good as well, with no stitches and no coloration area.The device history and raw material review showed: supplier (b)(4); reference: 03.000.402 (f87709).Batch: 603024/1, manufactured in january 2016 (qty: (b)(4)).Raw material: stainless steel aisi 431 (incoming inspection document in annex).Final manufacturing inspection: validated (document in annex).From a functional point of view, the tip still has a good vibration performance.The quality records have not recorded a previous complaint.No other tip from this batch number, has been reported as faulty.The final control was compliant and as no other complaints have been reported, this breakage is considered as isolated.No manufacturing related issue was identified and therefore review to the specific process risk management document.Possible root causes include: too high setting of the ultrasonic, lack of irrigation during treatment, and excessive strength during dental operation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SAW 20.1X21.4X4.0X0.6MM FOR PIEZOELECTRIC SYSTEM-STER
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACHMENT
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5978959
• MDR Text Key: 55683379
• Report Number: 2520274-2016-14696
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Catalogue Number: 03.000.402.98S
• Device Lot Number: 603024/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2016
• 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 Age: 30 YR