MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS OSCILL-SAW-ATTACHM F/532.001 532.010 532; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number UNK_PRODUCT

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 08/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from the (b)(6) that the saw attachment device fell apart and the small cogs, etc.Fell out from the mechanism.It was reported that this event did not occur in the operative field.It was not reported if the device was used in surgery, or if there was patient involvement reported.It was not reported if there were any delays in a scheduled surgical procedure or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

(b)(4).Device brand name, common device name, device product code, serial number, manufacturing facility, number and device manufacture date were documented as unknown in the initial report respectively.Subsequent follow-up with the customer, additional information was received; therefore, all these fields have been updated accordingly to reflect the information.Subsequent follow-up with the customer, additional information was received.It was reported that the event occurred during testing for an initial surgery.According to the reporter, the oscillating saw attachment device came apart after attaching the device to the small battery drive device.The reporter stated that, the event occurred before the device was given to the surgeon.It was reported that the entire attachment device started spinning around in circles.The device was then checked to ensure that it was properly attached and then tested again.However, the issue persisted.The user attempted to remove the attachment device from the small battery drive device and the attachment device came apart with one end left on the small battery drive device and the other end off, with three cogs and two metal rings falling out.It was further clarified that after attaching the attachment device to the small battery drive device, the nurse checked the attachment device by pressing the drill trigger.At that point, the attachment device ¿exploded¿ over the scrub nurse¿s table.According to the reporter, the saw device was not in contact with the patient or the operative site at time of the event.It was further reported that no fragments fell into the patient; it was only the scrub table that was affected.It was reported that there was no x-ray required.According to the nurse, sterility was compromised, but easily rectified.It was reported that the patient sterility was not compromised.There was a five minute delay to the surgical procedure.Spare devices were available to complete the surgery successfully.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: OSCILL-SAW-ATTACHM F/532.001 532.010 532
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5928749
• MDR Text Key: 81500224
• Report Number: 8030965-2016-14749
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_PRODUCT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1