MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SURGICAL BLADE IN PODIATRY PACK

Catalog Number	DYNJ26051K
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a plantar fasciotomy and resection of bone spur, after skin incision and after surgical site was opened with hemostat, the #15 surgical blade (from custom surgical tray) was used to resect deep tissue from around the bone spur.Reportedly, the surgical blade broke while resecting tissue around bone spur.During inspection prior to use, it was denied that there were there any issues noted at that time.It was also denied that excessive force was applied to or against the blade.After the broken pieces of the surgical blade reached the surgical site, the incision was extended and a hemostat was used with the aid of fluoroscopy to remove the broken blade.No impact to the patient or to the procedure was reported.No tests or treatment was required related to the reported incident.The patient was under monitored anesthesia care at the time of the incident and procedure took 15 minutes longer.The patient is reportedly recovering as expected.Due to the reported incident of surgical blade breaking and the medical intervention required to retrieve the broken pieces from the surgical site, this medwatch is being filed.The sample was returned for evaluation and complaint was confirmed.The surgical blade broke at the top of the cut out that is used to connect the blade to the handle.A definitive root cause for the reported issue 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 the surgical site and was successfully retrieved through aid of hemostat and fluoroscopy.

• Common Device Name: SURGICAL BLADE IN PODIATRY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9172380
• Report Number: 1423395-2019-00040
• Device Sequence Number: 14115646
• Product Code: OJH
• UDI-Device Identifier: 10888277993549
• UDI-Public: 10888277993549
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/09/2019

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: DYNJ26051K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/09/2019
• 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: 66 YR
• Patient Weight: 73