MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US P.F.C.* STEM EXTRACTOR; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number 853961

Device Problems Device-Device Incompatibility (2919); Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

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

During the procedure, the screw on the stem extractor was not able to be tightened smoothly.When the surgeon used an impactor to lightly hammer the upper area of the stem extractor, the screw appeared to be damaged.The procedure was delayed by 30 minutes.There was no harm to the patient.The device was the first use when the issue occurred.

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.

Manufacturer Narrative

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.Product complaint # (b)(4).Investigation summary the devices were all reviewed by bioengineering and a report was received stating it was unlikely that a manufacturing defect was present.No corrective action is required.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot null device history batch null device history review null if information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9745241
• MDR Text Key: 190663804
• Report Number: 1818910-2020-05753
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2020

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: 853961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 02/26/2020; 04/22/2020
• Supplement Dates FDA Received: 03/09/2020; 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1