MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BATT F/PD; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 530.200

Device Problems Loss of Power (1475); Low Battery (2584); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device was worn out and the capacity was low (50 percent).Therefore, the reported condition was confirmed.It was further determined that the device was defective and had no function.The assignable root cause was determined to be due to normal wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported from (b)(6) that during service and evaluation, it was observed that the battery device was worn out.It was further determined that the device had a low capacity (50%).It was noted in the service order that the device was defective and had no power.The 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: BATT F/PD
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5226064
• MDR Text Key: 31532358
• Report Number: 3009450871-2015-14220
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PEXEMPT
• 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: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.200
• Device Lot Number: C111104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2011
• 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