MAUDE Adverse Event Report: SYNTHES GMBH TI LCP PROX LATERAL TIBIA PL 5 HOLES/140MM/RIGHT-STERILE; PLATE, FIXATION, BONE

Model Number	422.220S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021, the patient underwent a surgery for a proximal tibia fracture with two plates.Removal surgery was performed on (b)(6) 2022.During the removal surgery, one screw that fixed one of the plates was difficult to extract.The surgeon cut the screw head with a carbide drill, which allowed the plate to be removed.The shaft of the screw that remained in the bone was extracted using a hollow reamer.This report is for a ti lcp prox lateral tibia pl 5 holes/140mm/right-sterile.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.

• Brand Name: TI LCP PROX LATERAL TIBIA PL 5 HOLES/140MM/RIGHT-STERILE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN; solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 14943415
• Report Number: 8030965-2022-04599
• Device Sequence Number: 6196084
• Product Code: HRS
• UDI-Device Identifier: 10886982215031
• UDI-Public: (01)10886982215031
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 07/06/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 422.220S
• Device Catalogue Number: 422.220S
• Device Lot Number: 4L51465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2019
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 50 KG