MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN GB OFFSET GRATER HANDLE; HIP INSTRUMENTS : HANDLES

Catalog Number 255000100

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 in central processing inspection when resetting instruments after decontamination and procedures and it was noticed that the reamer shaft stuck and was stiff on reassembly.Issues were not present or aware during procedures, no patient involvement.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

This product was reported in error.Depuy doesn¿t have the responsibility to make a reporting determination and submit adverse event reports for this instrument.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened. .

• Brand Name: PINN GB OFFSET GRATER HANDLE
• Type of Device: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8699919
• MDR Text Key: 148535331
• Report Number: 1818910-2019-95992
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2019

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 Catalogue Number: 255000100
• Device Lot Number: PC3662931
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 12/11/2019; 02/04/2020
• Supplement Dates FDA Received: 12/12/2019; 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1