MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DRILL FOR 8MM, 1,5X50MM, STRYKER, STERILE; INSTRUMENT

Model Number 91-15008

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/24/2023

Event Type  malfunction  

Event Description

It was reported that during the procedure, the red colored ring on the drill bit was noted to be missing, posing the risk of a small component being lost in a surgical site.There was no clinically significant delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.

Event Description

It was reported that during the procedure, the red colored ring on the drill bit was noted to be missing, posing the risk of a small component being lost in a surgical site.There was no clinically significant delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

Because the drill was discarded and no image for the drill could be provided the reported event cannot be confirmed.Summarizing all available information, the root cause of the reported event could not be determined.If additional information becomes available, the complaint will be reviewed.H3 other text : discarded.

• Brand Name: DRILL FOR 8MM, 1,5X50MM, STRYKER, STERILE
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 16497684
• MDR Text Key: 311096353
• Report Number: 0008010177-2023-00012
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 04546540493682
• UDI-Public: 04546540493682
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K070876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

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: 91-15008
• Device Catalogue Number: 91-15008
• Device Lot Number: 6000098170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1