MAUDE Adverse Event Report: OSTEOMED, LLC 2.0MM X 8MM MMF AUTO-DRIVE SCREW; SCREW, FIXATION, INTRAOSSEOUS

Model Number 209-2008

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/08/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported the broken piece of the screw will be returned for evaluation.Upon completion of the investigation, a follow up report will be submitted.

Event Description

It was reported during an orif procedure of the mandible, the surgeon was inserting the screw into the patient's mandible, and the screw head broke off.The break from the screw shank was clean/flush to the patient's bone.The remainder of the screw was left in the patient's mandible.The procedure was completed as planned.There were no adverse consequences to the patient and no delay in procedure.The batch/lot number of the reported screw is unknown.

Manufacturer Narrative

The device was received for evaluation on 16 september 2022.The reported event was confirmed as only a portion of the screw was returned and was fractured in the shaft of the screw with the broken portion not returned.Functional testing of the returned portion could not be conducted due to the damage.Additionally, review of manufacturing and inspection records could not be performed as device batch/lot number is unknown.Two year review of complaint history revealed only 1 other complaint for this part family which was unrelated to the medical device problem code of "break".Based on the information received and the investigation performed, the root cause of the reported event is unknown.

• Brand Name: 2.0MM X 8MM MMF AUTO-DRIVE SCREW
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• 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: 15397490
• MDR Text Key: 301853547
• Report Number: 2027754-2022-00046
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911936
• 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: 09/29/2022

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: 209-2008
• Device Catalogue Number: 209-2008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 09/10/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic