MAUDE Adverse Event Report: SYNTHES GMBH TI LCP PROXIMAL LATERAL TIBIA PL 7 HOLES/180MM-LEFT; PLATE, FIXATION, BONE

Model Number	422.223
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the doctor placed a tibial implant into the distal femur.The surgery was not complicated.This report involves one (1) ti lcp proximal lateral tibia pl 7 holes/180mm-left.This is report 1 of 1 for (b)(4).

• Brand Name: TI LCP PROXIMAL LATERAL TIBIA PL 7 HOLES/180MM-LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11655244
• Report Number: 8030965-2021-02783
• Device Sequence Number: 14327105
• Product Code: HRS
• UDI-Device Identifier: 10886982215086
• UDI-Public: (01)10886982215086
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K052390
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: 422.223
• Device Catalogue Number: 422.223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/13/2021
• Patient Sequence Number: 1
• Patient Age: 81 YR