MAUDE Adverse Event Report: SYNTHES GMBH OSCILLATING SAW ATTACHMENT

Catalog Number 511.80

Device Problems Device Difficult to Setup or Prepare (1487); Connection Problem (2900); Temperature Problem (3022)

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

Event Type  malfunction  

Event Description

It was reported that there was difficulty with attaching the hand piece, and the body heated up with key.There was no report of injury to patient or user.This is 1 of 1 report for #(b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities related to synthes (b)(6) and repair files legacy review/remediation protocol-complaint handling and mdr reporting.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.The part was returned and inspected.During the inspection the technician found the coupling power supply was damaged and not functioning.The noted observations are due to faulty handling.Device repaired and sent to customer on (b)(6) 2013.Placeholder.

• Brand Name: OSCILLATING SAW ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3941048
• MDR Text Key: 18921865
• Report Number: 8030965-2014-00434
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.80
• Device Lot Number: 6829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1