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

Model Number	4100131000
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Scrapped.
Event or Problem 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
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 12380304
• Report Number: 3015967359-2021-01917
• Device Sequence Number: 14437182
• Product Code: HRX
• UDI-Device Identifier: 04546540068170
• UDI-Public: 04546540068170
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K112593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

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
• Operator of Device: Health Professional
• Device Model Number: 4100131000
• Device Catalogue Number: 4100131000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1