MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS DRILL CHUCK 930 1/MIN W/KEY F/BPL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.730

Device Problems Break (1069); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

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.However, the assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported by (b)(6) that during service and evaluation, it was observed that the chuck with key device was broken, torn off.It was noted that the shaft was broken from the chuck, the blue marking was missing, and the machine coupling side was damaged.It was noted in the service order "the locking mechanism does not work." 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: DRILL CHUCK 930 1/MIN W/KEY F/BPL
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5825790
• MDR Text Key: 51350098
• Report Number: 8030965-2016-14353
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.730
• Device Lot Number: 3716094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2011
• 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