MAUDE Adverse Event Report: 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATE 1H/69MM; PLATE, FIXATION, BONE

Model Number	02.120.701
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2021, the tip of the drill bit broke off during insertion of the unk - screws: 3.5 mm cortex.The event occurred during an open reduction internal fixation (orif) of a left proximal tibia fx.The surgeon was drilling through the oblong hole of a 3.5mm lcp posteromedial plate using a 2.5mm drill bit with the 3.5mm non-locking drill guide.The angle of difficulty in relation to where the plate was positioned and how the leg was positioned made it difficult for the surgeon to aim the drill bit at the correct angle.He drilled through the oblong hole of the plate and into the near and far cortex without complication.As the surgeon backed out and retracted the drill bit from the far cortex, it was noticed that the tip of the drill bit was missing.An x-ray of the left proximal tibia showed that the tip of the drill bit was just anterior of the plate in the oblong hole of the 3.5 mm lcp posteromedial plate.The surgeon then took the plate off and proceeded to search for the missing tip of the 2.5mm drill bit.After suctioning, small needle-nose clamps were used in retrieving the missing tip of the 2.5mm drill bit.He then re-positioned the 3.5mm lcp posteromedial plate in the correct position and completed the case without any further complications.There was a ten (10) minute surgical delay.The surgery was completed successfully.The patient outcome was unknown.Concomitant device reported.3.5mm non-locking drill guide (part# 03.133.002, lot# unknown, qty 1).Unk - screws: 3.5 mm cortex (part# unknown, lot# unknown, qty 1).This report is for one (1) 3.5mm lcp posteromedial proximal tibia plate 1h/69mm.This is report 2 of 2 for (b)(4).

• Brand Name: 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATE 1H/69MM
• Common Device Name: PLATE, FIXATION, BONE
• MDR Report Key: 12728028
• Report Number: 2939274-2021-06388
• Device Sequence Number: 1559085
• Product Code: HRS
• UDI-Device Identifier: 10886982040206
• UDI-Public: 10886982040206
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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: 02.120.701
• Device Catalogue Number: 02.120.701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5 DRILL BIT QC 170 80 CALIBRATION; 3.5MM NON-LOCKING DRILL GUIDE; UNK - SCREWS: 3.5 MM CORTEX