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

Catalog Number 530.705

Device Problems Unintended System Motion (1430); No Fail-Safe Mechanism (2990)

Patient Problem No Patient Involvement (2645)

Event Date 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by (b)(4) that during service and evaluation, it was determined that the control unit was not functioning and was defective on the battery reamer/drill device.It was further determined that the device was without function.It was further determined that the device failed pretest for functional test.It was noted in the service order that the device had an undetermined malfunction.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should available, a supplemental medwatch 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7125335
• MDR Text Key: 95732357
• Report Number: 8030965-2017-16332
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.705
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• 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