MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PK-ORTHO-SCOPE-SHLDR

Catalog Number	DYNJ50468D
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer on (b)(6) 2024, "the surgeon was making an incision to complete tear in shoulder" when the "11 blade broke in half while inside the patient".
Additional Manufacturer Narrative
According to the customer on (b)(6) 2024, "the surgeon was making an incision to complete tear in shoulder" when the "11 blade broke in half while inside the patient".The customer reported that the blade was "retrieved with a grasper" and that "no serious injury occurred and no follow-up was needed".The customer reported that the "patient is fine".The customer reported that there is no sample available.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.

• Common Device Name: PK-ORTHO-SCOPE-SHLDR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 18827849
• Report Number: 1423395-2024-00117
• Device Sequence Number: 18112734
• Product Code: OJH
• UDI-Device Identifier: 10193489733334
• UDI-Public: 10193489733334
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNJ50468D
• Device Lot Number: 23LBB093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown