MAUDE Adverse Event Report: OSTEOMED, LLC 2.7 X 12MM FULLY THREADED ANGLED LOCKING

Model Number	338-2712
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the review of the dhr, no abnormalities were found.There are no units of this lot currently in warehouse inventory.There were no failure trends identified for this part.The device was not explanted.However, x-ray photos were provided and confirm the broken plate.There also have been no nonconformances (ncrs) or capas for this part in the past 2 years (aug 2019 - july 2021).This complaint is the only one reported for this part.The data collected for this complaint states the implant has not yet been explanted.This new plate and screw order may be established through the applicable distribution channel.The doctor indicates that he has no signs that the patient has exposed the plate to fatigue.There are adequate user instructions and warnings for potential device failures in the instruction for use and surgical technique guide.The risk of this type of failure mode is adequately addressed in fmea-0909 rev k, and carries a severity level of 3 for nonunion, misaligned fusion, and/or tissue irritation.Based on this investigation, no root cause could be determined.No further actions will be taken at this time.Complaints will continue to be monitored and trended.The device will be evaluated once received and a supplemental report will be submitted.Note: complaint investigation results in this report is applicable to 2.7 x 12mm fully threaded angled locking, part number 338-2712 / lot # 1129482.For the associated screws investigation, results refer to the respective mdr #: mdr # part number description lot # quantity 2027754-2021-00004 336-2710 2.7 mm 10 hole subcondylar plate 1139811 1.2027754-2021-00005 338-2710 2.7 x 10mm fully threaded angled locking 1129481 2.2027754-2021-00007 338-2716 2.7 x 16mm fully threaded angled locking 1128465 1.2027754-2021-00008 338-2718 2.7 x 18mm fully threaded angled locking 1136613 1.
Event or Problem Description
On (b)(6) 2021 osteomed was notified that, during a follow up visit due to discomfort on the the left foot of the patient; the x-ray's from (b)(6) 2021 reflects that the plate implanted on (b)(6) 2020 was broken.Per the reporter: "the patient presented discomfort and at the time of the review it was detected that the plate (336-2710) had fractured, the doctor indicates that he has no signs that the patient has exposed the plate to fatigue." the involved part numbers are as follows: part number description lot # quantity 336-2710 2.7 mm 10 hole subcondylar plate 1139811 1.338-2710 2.7 x 10mm fully threaded angled locking 1129481 2.338-2712 2.7 x 12mm fully threaded angled locking 1129482 1.338-2716 2.7 x 16mm fully threaded angled locking 1128465 1.338-2718 2.7 x 18mm fully threaded angled locking 1136613 1.

• Brand Name: 2.7 X 12MM FULLY THREADED ANGLED LOCKING
• Common Device Name: 2.7 X 12MM FULLY THREADED ANGLED LOCKING
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• MDR Report Key: 12285265
• Report Number: 2027754-2021-00006
• Device Sequence Number: 3531716
• Product Code: HWC
• UDI-Device Identifier: 00845694042567
• UDI-Public: (01)00845694042567(10)1129482(30)1(11)180824
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K131445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: 338-2712
• Device Catalogue Number: 338-2712
• Device Lot Number: 1129482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 08/05/2021
• 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