MAUDE Adverse Event Report: SYNTHES OBERDORF BATTERY REAMER/DRILL II HANDPIECE; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.705

Device Problems Break (1069); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Contamination with Body Fluid (2317); Mechanical Jam (2983); Naturally Worn (2988); Power Problem (3010)

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

Event Date 10/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to improper maintenance, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported by (b)(6) that the handpiece device was not working.During service and evaluation, it was observed that the handpiece device motor seized, jammed, and was heavy moving.It was noted that there was very thick and hard debris of blood and bone particles found inside which was causing a heat problem, and damaged the gear assembly.It was also noted that the device failed pre-repair diagnostic tests for general condition, trigger and ecu function, and power at the motor with test bench.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BATTERY REAMER/DRILL II HANDPIECE
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6077233
• MDR Text Key: 59466637
• Report Number: 8030965-2016-15449
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2016
• Date Manufacturer Received: 10/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2014
• 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