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

Catalog Number 530.705

Device Problems Crack (1135); Mechanical Jam (2983); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by (b)(6) that during service and evaluation, it was observed that the battery reamer/drill device had a broken/torn off housing, jammed trigger and fall damage.It was noted in the service order that the device had a cracked handle.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.

Manufacturer Narrative

This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the housing was broken and torn off.Therefore, the reported condition was confirmed.It was further determined that the trigger was jammed and the device had a fall damaged.The assignable root cause was determined to be due to faulty/improper handling.This was further defined as user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be sent 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5247122
• MDR Text Key: 32212220
• Report Number: 8030965-2015-11873
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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,Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2014
• 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