MAUDE Adverse Event Report: ASPEN SURGICAL ASPEN SURGICAL; SURGICAL BLADE IN CUSTOM ORTHO SHOULDER SCOPE TRAY

Catalog Number	PHS393024007A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that while surgeon was making a skin incision during a shoulder arthroscopy, the #11 surgical blade (taken from custom orthopedic pack) broke.Reportedly, all of the blade's broken pieces were successfully retrieved through an unidentified method.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.No impact to the patient, the staff, the procedure, or the total length of the procedure was reported.Per report, the patient was discharged the same day and is appropriately recovering at this time.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.The manufacturer of the surgical blade has been notified.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that while surgeon was making a skin incision during a shoulder arthroscopy, the #11 surgical blade (taken from custom orthopedic pack) broke.

• Brand Name: ASPEN SURGICAL
• Common Device Name: SURGICAL BLADE IN CUSTOM ORTHO SHOULDER SCOPE TRAY
• Manufacturer (Section D): ASPEN SURGICAL; caledonia MI 49316
• MDR Report Key: 8557667
• Report Number: 1423395-2019-00011
• Device Sequence Number: 19419666
• Product Code: OJH
• UDI-Device Identifier: 10889942689866
• UDI-Public: 10889942689866
• 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): 04/26/2019

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: PHS393024007A
• 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: 04/26/2019
• 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: 56 YR
• Patient Weight: 82