MAUDE Adverse Event Report: SYNTHES GMBH TI LCP DISTAL FEMUR PLATE 9 HOLES/236MM/LEFT-STERILE; PLATE,FIXATION,BONE

Catalog Number	422.255S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on unknown date, the patient underwent tka surgery.After the tka surgery, on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for supracondylar fracture of left posterior femur with the plate in question.The surgery was completed with no surgical delay.After surgery, on unknown date, when the patient visited the hospital complaining of pain and an x-ray was taken, breakage of the plate was confirmed.The patient will undergo revision surgery on (b)(6) 2021.In the revision surgery, iliac bone graft and chipping of fracture will be performed, and the plate will be replaced with a new one.It was unknown if the revision surgery completed successfully.The patient condition is stable.Concomitant device reported: unknown locking screws (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.This report is for (1) ti lcp distal femur plate 9 holes/236mm/left-sterile.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: TI LCP DISTAL FEMUR PLATE 9 HOLES/236MM/LEFT-STERILE
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13003950
• Report Number: 8030965-2021-10215
• Device Sequence Number: 19286832
• Product Code: HRS
• UDI-Device Identifier: 07611819289635
• UDI-Public: (01)07611819289635
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062564
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 422.255S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/14/2021
• 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: UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female