MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO WIRE COLLET; ARTHROSCOPE

Model Number 4100062000

Device Problems Material Disintegration (1177); Material Fragmentation (1261)

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

Event Date 02/12/2021

Event Type  malfunction  

Event Description

The user facility reported that the device had black powder coming out during testing.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

Additional information: d10.Device evaluation: follow-up report submitted to document device evaluation results.

Event Description

The user facility reported that the device had black powder coming out during testing.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: WIRE COLLET
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11435352
• MDR Text Key: 238360078
• Report Number: 3015967359-2021-00087
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04546540068354
• UDI-Public: 04546540068354
• Combination Product (y/n): N
• PMA/PMN Number: K943323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4100062000
• Device Catalogue Number: 4100062000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1