MAUDE Adverse Event Report: OSTEOMED, LLC DEPTH GAUGE, 6.5/7.3MM; SCREW, FIXATION, BONE

Model Number	316-0017
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the triple ankle arthodesis surgery, the specialist decides to place a canulated screw with a 6.5mm head from the canulated set.At the time of placing this screw, the specialist implants a 2.8 guide and when he is going to enhance the measurement with the depth gauge (part number 316-0017), it was noted the guide did not go through the depth gauge.The specialist tried to change guides but none of the guides in the set went through the depth gauge, the specialist measured with the help of another guide to complete the surgery.This prolonged the surgery by 35 minutes.No other adverse patient consequences were reported.
Additional Manufacturer Narrative
It was reported that the wire in the accompanying set, 2.8mm guidewire, would not fit through the depth gauge, 316-0017.The depth gauge was returned for evaluation and inspection revealed a laboratory wire did not fit through the depth gauge, which confirms the reported event.The opening was measured by quality control and confirmed there is a misalignment potentially caused during welding.Review of the dhr revealed all inspections passed with no anomalies identified.There was no remaining inventory of this part number and lot number for review.A review of complaint history revealed no other complaints for part number 316-0017.

• Brand Name: DEPTH GAUGE, 6.5/7.3MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 18318291
• Report Number: 2027754-2023-00074
• Device Sequence Number: 6278366
• Product Code: HWC
• UDI-Device Identifier: 00845694035613
• UDI-Public: (01)00845694035613(10)1167639(30)1(11)220228
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: 316-0017
• Device Catalogue Number: 316-0017
• Device Lot Number: 1167639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Hispanic