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

Catalog Number	PHS393024007A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the post-operative x-ray revealed that the #11 blade (from the custom orthopedic tray) was retained in patient's left shoulder.Per report, on (b)(6) 2019, patient underwent left shoulder arthroscopy, labral repair with capsulorrphaphy, and cyst decompression.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.Reportedly, the patient was discharged to home the same day.On (b)(6) 2019, the patient presented to the emergency department for a syncopal episode.The patient was also reportedly having post-operative shoulder pain at that time.The patient was discharged to home and was told to follow-up with his primary care physician in two days.Per report, the patient went to see his surgeon for follow-up and surgeon ordered the left shoulder x-ray, which showed the retained blade.It was reported that the patient was taken to another facility for the retained blade to be retrieved.The patient reportedly recovered from the retrieval operation with no further adverse effects.Due to the reported event and required medical intervention to retrieve the retained device, 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 the post-operative x-ray revealed that the #11 blade (from the custom surgical tray) was retained in patient's left shoulder.

• Brand Name: ASPEN SURGICAL
• Common Device Name: SURGICAL BLADE FROM CUSTOM ORTHO SHOULDER SCOPE TRAY
• Manufacturer (Section D): ASPEM SURGICAL; caledonia MI 49316
• MDR Report Key: 8557895
• Report Number: 1423395-2019-00013
• Device Sequence Number: 13837294
• 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: 25 YR
• Patient Weight: 79