DEPUY SYNTHESIS POWER EQUIPMENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-22 for DEPUY SYNTHESIS POWER EQUIPMENT manufactured by Depuy.

Event Text Entries

[103351820] This is a f/u report for depuy report filed 01/21/2018 fluid in depuy handheld surgical devices. We have worked extensively with depuy to change our sterilization practices but we continue to have residual moisture continued after all depuy recommendations were followed. Serial numbers: (b)(4). Ref mw5074763.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5076071
• MDR Report Key: 7366213
• Date Received: 2018-03-22
• Date of Report: 2018-03-20
• Date Added to Maude: 2018-03-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: DEPUY SYNTHESIS POWER EQUIPMENT
• Generic Name: HANDHELD SAW
• Product Code: HSO
• Date Received: 2018-03-22
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY

Device Sequence Number: 2

• Brand Name: DEPUY SYNTHESIS POWER EQUIPMENT
• Generic Name: HANDHELD SAW
• Product Code: HSO
• Date Received: 2018-03-22
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: DEPUY

Device Sequence Number: 3

• Brand Name: DEPUY SYNTHESIS POWER EQUIPMENT
• Generic Name: HANDHELD SAW
• Product Code: HSO
• Date Received: 2018-03-22
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: DEPUY

Device Sequence Number: 4

• Brand Name: DEPUY SYNTHESIS POWER EQUIPMENT
• Generic Name: HANDHELD SAW
• Product Code: HSO
• Date Received: 2018-03-22
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: DEPUY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2018-03-22