MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PERFORATOR CHUCK; MOTOR, DRILL, PNEUMATIC

Model Number 5400210060

Device Problems Break (1069); Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.1 device was not labeled for single-use.1 device was not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event in which the device had a broken cutting accessory still attached.1 event had no patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h6 medical device problem code.

Event Description

This report summarizes 1 malfunction event in which the device or cutting accessory fractured.1 event had no patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h10 1 event was previously reported during the reporting period; however, - 1 previously reported event in this report should have been included under mfr report # 0001811755-2020-01916.- 0 previously reported events are included in this follow-up record.

Event Description

This report summarizes 0 malfunction events in which the device or cutting accessory fractured.

• Brand Name: PERFORATOR CHUCK
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 10329647
• MDR Text Key: 200646690
• Report Number: 0001811755-2020-01844
• Device Sequence Number: 1
• Product Code: HBB
• UDI-Device Identifier: 04546540469229
• UDI-Public: 04546540469229
• Combination Product (y/n): N
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2021

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: No Information
• Device Model Number: 5400210060
• Device Catalogue Number: 5400210060
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 06/30/2020; 06/30/2020
• Supplement Dates FDA Received: 07/28/2020; 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1