MAUDE Adverse Event Report: SYNTHES GMBH HAND PIECE FOR BATTERY POWERED DRIVER; SCREWDRIVER, SKULLPLATE

Model Number 05.000.008

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional device product codes: hxx, hwe e3: reporter is a j&j employee.H3, h4, h6: service and repair evaluation: the customer reported that the 05.000.008, hand piece for battery powered driver was submerged in water.The repair technician reported that the device did not run in fast forward, forward and reverse.The cause of the issue is unknown.The item will be repaired per the inspection sheet and returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.Device history lot: part# 05.000.008 synthese lot # 003701 supplier lot # 003701 release to warehouse date: 27 aug 2010 supplier: triangle manufacturing review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Device was used for treatment, not diagnosis.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 the hand piece for battery powered driver was believed to have been submerged in water.No further information is available.This report involves one hand piece for battery powered driver.This is report 1 of 1 for (b)(4).

• Brand Name: HAND PIECE FOR BATTERY POWERED DRIVER
• Type of Device: SCREWDRIVER, SKULLPLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17269625
• MDR Text Key: 318555524
• Report Number: 8030965-2023-08404
• Device Sequence Number: 1
• Product Code: GXL
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Model Number: 05.000.008
• Device Catalogue Number: 05.000.008
• Device Lot Number: 003701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2010
• 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