MAUDE Adverse Event Report: OSTEOMED, LLC HEMI GREAT TOE IMPLANT, MEDIUM; PROSTHESIS, TOE, HEMI-, PHALANGEAL

Model Number 375-0003

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

Event Description

It was reported during a hemi arthroplasty procedure, the surgeon struggled to get the osteomed hemi great toe implant in.The surgeon noted that the punch instrument was significantly smaller than the implant, and the surgeon had to soften the punched area with a k-wire and then a drill to get the implant to fit in.It was reported this issue prolonged the procedure by 20-30 minutes, and it was difficult to tell if the implant was tight or loose when the surgeon finally got the implant seated.This report is related to report number 2027754-2023-00002 for the punch instrument involved in this event.

Manufacturer Narrative

The investigation is currently pending, and a follow up report will be submitted upon completion of the investigation.The hemi implant was reportedly implanted; however, it was stated the instrumentation is available for return.

Manufacturer Narrative

One (1) hemi instrument kit was returned for evaluation, and no issues were identified with the re-usable hemi punch.The hemi medium implant was not returned for evaluation, as it was implanted during the reported event.No ncrs or capas were identified for the hemi instruments or implants in the two year review.This is the first reported complaint for the hemi instruments and implants identified in the review.The reported complaint states that the implant was significantly larger than the punch instrument; however, a drawing review identified that both the implant and punch are machined to the same angle.A review of the device history record revealed no anomalies.Based on the information received and the investigation performed, the root cause could not be determined.

• Brand Name: HEMI GREAT TOE IMPLANT, MEDIUM
• Type of Device: PROSTHESIS, TOE, HEMI-, PHALANGEAL
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: ellie wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 16309369
• MDR Text Key: 309395025
• Report Number: 2027754-2023-00001
• Device Sequence Number: 1
• Product Code: KWD
• UDI-Device Identifier: 00845694011761
• UDI-Public: (01)00845694011761(10)1159186(30)1(17)250620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

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
• Device Operator: Health Professional
• Device Model Number: 375-0003
• Device Catalogue Number: 375-0003
• Device Lot Number: 1159186
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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