MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1/4" DRILL WITH KEY; ARTHROSCOPE

Model Number 4100131000

Device Problem Material Disintegration (1177)

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

Event Date 08/04/2021

Event Type  malfunction  

Event Description

The user facility reported that the device had metal shavings coming out during a procedure.  there was no patient impact, no delay, no medical intervention, and no adverse consequences.

• Brand Name: 1/4" DRILL WITH KEY
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 12391684
• MDR Text Key: 268923229
• Report Number: 3015967359-2021-01934
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04546540068170
• UDI-Public: 04546540068170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4100131000
• Device Catalogue Number: 4100131000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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