MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BATTERY REAMER/DRILL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.605

Device Problems Device Stops Intermittently (1599); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition that the device was not working was confirmed.An assessment was performed which found that the housing of the device was cracked, the trigger was sticking, and the device was running intermittently.During service and repair it was observed that the housing was cracked, the trigger assembly was corroded, the gears and gear bow were corroded, and the contacts on the motor were corroded.The assignable root causes of these conditions were determined to be due to improper handling and improper cleaning methods, 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 from (b)(6) that the battery reamer / drill device was not working.During in-house engineering evaluation it was determined that the housing of the device was cracked and running intermittently, and the trigger was sticking.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 the event was not reported, however, it was reported that the event occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: BATTERY REAMER/DRILL
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES PRODUKTIONS GMBH; hauptstrasse 24; waldenburg 4437 ; SZ 4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7592885
• MDR Text Key: 110848933
• Report Number: 8030965-2018-54265
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819137103
• UDI-Public: (01)7611819137103(11)111206
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Date Manufacturer Received: 05/23/2018
• Date Device Manufactured: 12/06/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1