MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH OSCILLATING SAW ATCH, LARGE, WITH KEY; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number 532.026

Device Problems Output below Specifications (3004); Noise, Audible (3273)

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

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that during a veterinary tibial plateau leveling osteotomy (tplo) procedure on an animal, it was observed that the cutting action on the oscillating saw attachment device slowed down and made a grinding sound.According to the report, the event occurred when the saw blade device was connected to the device and was tried to cut the bone.There was an unspecified delay there was a delay to the surgical procedure as a spare device was retrieved.There was no human patient involvement as this was a veterinary procedure.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Correction: concomitant medical devices: the date device returned to manufacturer was documented as 3/6/2018 in the initial report.It has been updated as this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the bearing was seized, jammed and moving heavily.Therefore, the reported condition was confirmed.It was further determined that the needle bearing was blocked, device had too little power and grinding noise.It was further determined that the device failed pretest for check frequency.10800 to 13200 osc/min.The assignable root cause could not be determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Correction: the date device returned to manufacturer was documented as 3/12/2018 in the initial report.It has been updated as 3/08/2018.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• Brand Name: OSCILLATING SAW ATCH, LARGE, WITH KEY
• Type of Device: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7371268
• MDR Text Key: 103532849
• Report Number: 8030965-2018-52425
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 7611819996069
• UDI-Public: (01)7611819996069(11)140219
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.026
• Device Lot Number: 100092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Date Manufacturer Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1