MAUDE Adverse Event Report: SYNTHES USA SAW ROUND 38.9*Ø5 Ø0.6 F/PIEZOELECTRIC S; DRILL, BONE, POWERED

Catalog Number 03.000.424S

Device Problem Break (1069)

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

Event Date 05/06/2016

Event Type  malfunction  

Manufacturer Narrative

(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)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.Without a valid lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during a lefort i osteotomy surgery the piezo sawblade broke.A spare device as available and the procedure was successfully completed.No additional medical intervention was needed.There was no patient harm reported; there was no undesired treatment or outcome; the patient outcome was reported to be as planned.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

A manufacturing evaluation was completed: the received saw was broken around the connecting thread.Signs of improper use can be observed.There are slight damages to the saw teeth and the bow but most important are the circular fractures around the coupling thread.No temper colors can be seen.That indicates that the breakage might be due to excessive mechanical stress but not necessarily due to overheating.Most likely the saw blades broke due to excessive mechanical stress applied.There is no clear evidence whether this mechanical stress was applied during surgery or whether the saw blades were damaged already before during coupling to the hand piece.A special torque limiter key has to be used for coupling the saw blades to the hand piece in order to avoid too high torque being applied.The device manufacturing documentation was reviewed and no deviations were found.(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.

• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5681916
• MDR Text Key: 45998869
• Report Number: 2520274-2016-12881
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.000.424S
• Other Device ID Number: GTIN: 07611819498426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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