MAUDE Adverse Event Report: SYNTHES SELZACH CONSOLE FOR PIEZOELECTRIC SYSTEM; DRILL, BONE, POWERED

Catalog Number 05.001.400

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is unknown.Additional product codes: erl, hbe, hwe.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported a piezo system didn't work during a procedure.Another one was available but had to be retrieved; this created a forty-five (45) minute delay in the procedure.It was reported that the irrigation system worked but there was no piezo effect on the saw tip.There was no adverse effect on the patient due to the delay; the patient's status post-operatively was reported as good.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device history/service record review: manufacturing date: november 25, 2014.Device manufactured by (b)(4), delivered and released for distribution in (b)(4).Business group: power tools.Service history review shows that the tool has been repaired after manufacture.The service & repair process involves component exchange and assembly/disassembly of the device therefore this documentation is reviewed as last valid device history record.Each of the services below have been performed by the subcontractor.For the service performed on august 17, 2015: no failure was found.For the service performed on november 10, 2015: motor pump was damaged and changed.Conformity of the product has been confirmed and documented through repair verification.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: CONSOLE FOR PIEZOELECTRIC SYSTEM
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5451562
• MDR Text Key: 38709958
• Report Number: 3000270450-2016-10037
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.400
• Device Lot Number: 208107.003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2014
• 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