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

Catalog Number 03.000.401S

Device Problem Break (1069)

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

Event Date 09/08/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the saw breakage during use.A new saw was mounted and used to complete.This is report number 1 of 1 for (b)(4).

Manufacturer Narrative

Additional product codes : erl, hbe, hwe.(b)(6).Without a lot number the device history records review could not be completed.Subject device has been received and is currently in the evaluation process.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.The visual inspection of the returned device performed as part of the manufacturing investigation reported the piezo saw is broken into three pieces.It is also visible that the shaft of the returned part is bent.The investigation was not able to determine the exact cause which led to this occurrence.However, due to the damaged at the shaft the complaint condition is likely the result of too much mechanical force applied during the surgery, or the article came in contact with hard material (metal for example).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The lot number provided could not be verified due to damage to the device; therefore, further investigation cannot be performed.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

There was reportedly a five minute delay in the procedure.

• Brand Name: SAW 20.9X14.1X4.0X0.6MM FOR PIEZOELECTRIC SYSTEM-STER
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4137108
• MDR Text Key: 4950008
• Report Number: 2520274-2014-13894
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.000.401S
• Device Lot Number: 602266/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 10/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/16/2014; 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1