MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ARTHROSCOPY PACK

Catalog Number DYNJ39104C

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/09/2022

Event Type  Injury  

Event Description

It was reported by the facility that during a 'knee scope' a number 11 blade from an arthroscopy pack is broke during use and needed to be removed from the patient.

Manufacturer Narrative

It was reported by the facility that during a 'knee scope' a number 11 blade from an arthroscopy pack is broke during use and was successfully removed from the patient.The sample was not returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: ARTHROSCOPY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13624886
• MDR Text Key: 286317236
• Report Number: 1423395-2022-00005
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ39104C
• Device Lot Number: 21KBK910
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 136 KG