MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN_INSTRUMENTS_PRODUCT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number 5407100000

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/24/2022

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure, the tip broke.It was further reported that fluoroscopy used to confirm no other pieces remained.It was also reported that the event caused a two minute delay to the procedure.It was also reported there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

Update: d9, h3, h6 device evaluation: follow-up report submitted to document the device was not available for evaluation.

Event Description

It was reported that during a surgical procedure, the tip broke.It was further reported that fluoroscopy used to confirm no other pieces remained.It was also reported that the event caused a two minute delay to the procedure.It was also reported there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: UNKNOWN_INSTRUMENTS_PRODUCT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 14524488
• MDR Text Key: 292832873
• Report Number: 3015967359-2022-01074
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 07613327096378
• UDI-Public: 07613327096378
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

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: 5407100000
• Device Catalogue Number: UNK_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 01/02/2023
• Supplement Dates FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 5407100000, UNKNOWN SN