MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHORT HUMERAL DISTAL STEM; HUMERAL STEM

Catalog Number	04.01.0182
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 26 july 2018: lot 172589: (b)(4) items manufactured and released on 15 may 2017.Expiration date: 2022-05-03.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
During surgery it was noticed that there is extreme difficulty disengaging the final short stem implant from the assembly tool.The surgeon dropped the head and stem as a result of the difficulty using the instruments.The surgeon upsized the implants.There was a delay of approximately 10 minutes.The surgery was completed successfully.

• Brand Name: SHORT HUMERAL DISTAL STEM
• Common Device Name: HUMERAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7731859
• Report Number: 3005180920-2018-00564
• Device Sequence Number: 11023054
• Product Code: KWS
• UDI-Device Identifier: 07630040715904
• UDI-Public: 07630040715904
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K180089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2022
• Device Catalogue Number: 04.01.0182
• Device Lot Number: 172589
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/30/2018
• 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: Other