MAUDE Adverse Event Report: SYNTHES SELZACH SAW 20.9X14.1X4.0X0.6MM FOR PIEZOELECTRIC SYSTEM-STER; DRILL, BONE, POWERED

Catalog Number 03.000.401.98S

Device Problem Break (1069)

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

Event Date 07/08/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).(b)(4).Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient underwent a planned orthognathic surgery on (b)(6) 2016.The surgeon was making a cut with the saw blade into the right jaw.The saw blade broke and one fragment was generated.The fragment was easily retrieved without additional intervention.The surgeon finished the procedure with a back-up device and the surgery was successfully completed.There was a surgical delay of approximately thirty to sixty seconds.This complaint involves one device.(b)(4).

Manufacturer Narrative

(b)(4).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.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

The patient status outcome is stable.

Manufacturer Narrative

Device history record (dhr) review: the lot number reported etched on the device corresponds to manufacturer part 03.000.401s, lot 0865818 applied during the packaging and sterilization process.Manufacturing date: march 02, 2016.Shelf life expiry date: january 31, 2021.Manufacturing location: supplier (b)(4).Device 03.000.401s is a batch number controlled product, therefore no service history record review is possible.No non-conformance reports were referenced to the production and quality inspection processes.The conclusion of the dhr 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.A manufacturing evaluation was completed: the shaft of the saw broke off approximately 5 mm above the saw blade.Additionally, the round part of the shaft is bent upwards at the connection to the coupling part.The saw for the piezoelectric system requires very slight pressure to be used effectively.Application of higher pressure may lead to the problem where the saw blade gets stuck within the bone and cannot move and thus cut any more.Finally the saw can break.The fact that the shaft is bent upwards clearly indicates that higher pressure has been applied during cutting and that most likely the saw broke off as a result of this.The most probable root cause is that too much pressure was applied during use and the saw broke off due to this mishandling.No manufacturing related issue was identified and/or confirmed.Manufacturing facility; catalog and udi number: (b)(4).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.Additional investigation by synthes customer quality was performed for the subject device (brand name saw 20.9x14.1x4.0x0.6mm for piezoelectric system-ster, part number 03.000.401.98s, lot number 0865818).The subject device was returned to the manufacturer with the complaint condition stating that saw blade broke intraoperatively and a fragment was generated.The fragment was easily retrieved without additional intervention.The surgeon finished the procedure with a back-up device and the surgery was successfully completed.The complaint condition was confirmed.The most probable root cause is that too much pressure was applied during use and the saw broke off due to this mishandling.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.No manufacturing related issue was identified and/or confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SAW 20.9X14.1X4.0X0.6MM FOR PIEZOELECTRIC SYSTEM-STER
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5822008
• MDR Text Key: 50414506
• Report Number: 2520274-2016-13603
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 03.000.401.98S
• Device Lot Number: 0865818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• 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: 18 YR