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

Catalog Number 530.705

Device Problem Mechanical Jam (2983)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Device evaluation: the actual device was returned for evaluation.A visual and functional assessment was performed which determined that the unit failed the trigger test check- trigger was binding.During service/repair, it was observed that the back end of the motor was corroded.It was determined that there was an unknown liquid on the gear reamer and on the electronic control unit (ecu).It was observed that the cent-sleeve was worn.It was determined that the issues were consistent with improper cleaning and normal wear.Therefore, the reported condition was confirmed.The assignable root cause of the sticky trigger was determined to be due to normal wear out from use.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that during an in-house laboratory course, it was discovered that the battery reamer/drill device was not working.During in-house engineering evaluation, it was observed that the unit failed the trigger test check- trigger was binding.It was reported that the device had never been used in a surgical setting with a live patient.The event was not related to surgery.There was no patient involvement.There were no reports of user injuries, medical intervention or prolonged hospitalization.The exact date of the 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 FOR BPL II
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8790364
• MDR Text Key: 151032042
• Report Number: 8030965-2019-66230
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 10886982240125
• UDI-Public: 10886982240125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2019

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: 06/14/2019
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 07/15/2019
• Date Device Manufactured: 02/22/2016
• 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