MAUDE Adverse Event Report: SYNTHES OBERDORF CASING FOR 14.4V BATTERY; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 532.032

Device Problems Failure to Charge (1085); Corroded (1131); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2015

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device contacts were corroded and the locking mechanism lid was missing a screw.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to loctite degradation from repeated sterilization and cleaning from normal use and servicing over time.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 that during a routine inspection, it was observed that the casing for battery device did not charge or close.During in-house engineering evaluation, it was observed that the device contacts were corroded and the locking mechanism lid was missing a screw.The event did not occur during surgery.There was no patient involvement reported.There were no reports of injuries, adverse events or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The manufacturer location was documented as waldenburg in the initial report.The location has been updated to (b)(4).Contact office name/address have been updated accordingly to reflect the corrected manufacturing facility.The device manufacture date was documented as july 23, 2009 in the initial report.The device manufacture date has been updated as august 30, 2005.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CASING FOR 14.4V BATTERY
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• 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: 5061470
• MDR Text Key: 25879949
• Report Number: 3009450871-2015-13262
• Device Sequence Number: 1
• Product Code: MOQ
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.032
• Device Lot Number: 007635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2005
• 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