MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SURGICAL BLADE FROM CUSTOM ARTHROSCOPY TRAY

Catalog Number	PHS393039010A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a knee scope procedure, the surgical blade that was used for incision came off its handle, falling inside the patient's knee cavity.It was added that while retrieving the blade, the blade broke into four pieces.Reportedly, the two large pieces of the broken blade were immediately retrieved and the third piece was retrieved with aid of c-arm (imaging device).The blade was reassembled and it was discovered that the tip (2mm) of blade was still missing.A plain film was obtained in anterior/posterior and lateral views and this was read by a radiologist, who confirmed that there was no visible remnant of blade retained in patient.Per report, it is believed that the missing piece had been flushed out with arthroscopic irrigation.It is unknown if any issue was noted with the surgical blade during inspection prior to use and whether any excessive force was applied to or against the blade during use.The patient was reportedly discharged the same day and recovered appropriately.General anesthesia was used and there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.No impact to the patient, the staff, the procedure, or the total length of the procedure was reported.Due to the reported event and medical intervention required to retrieve the broken pieces of the surgical blade, this medwatch is being filed.The sample has been discarded and is not available to be returned for evaluation.A definitive root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the surgical blade broke into four pieces.

• Common Device Name: SURGICAL BLADE FROM CUSTOM ARTHROSCOPY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8565196
• Report Number: 1423395-2019-00012
• Device Sequence Number: 2191498
• Product Code: OII
• UDI-Device Identifier: 10889942689873
• UDI-Public: 10889942689873
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PHS393039010A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 102