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

Catalog Number PHS393024007A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2019

Event Type  malfunction  

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 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
• Type of Device: SURGICAL BLADE IN CUSTOM ORTHO SHOULDER SCOPE TRAY
• Manufacturer (Section D): ASPEN SURGICAL; caledonia MI 49316
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8557667
• MDR Text Key: 145772272
• Report Number: 1423395-2019-00011
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10889942689866
• UDI-Public: 10889942689866
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PHS393024007A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 82