MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LCP DISTAL FEMUR PLATE 5 HOLES/156MM/RIGHT-STERILE; PLATE, FIXATION, BONE

Catalog Number 422.250S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2016, the patient underwent an osteosynthesis for the distal femoral fracture with the locking compression-distal femur (lcp-df) plate.The surgery was completed successfully.On (b)(6) 2021, the patient underwent the removal surgery of the lcp-df plate for the total knee arthroplasty (tka) surgery.During the removal surgery, the surgeon could not remove the four distal locking screws by using the driver, because distal locking screws were firmly fixed to the plate.The surgeon could remove one of the four distal locking screw by using the extraction screw.However, when the surgeon tried to remove two of four distal locking screw, the extraction screw broke in the screwhead.The fragment was remained in the screwhead.The surgeon tried to remove them by using a carbide drill, and he could finally remove the plate by digging the plate near the distal locking screw which was difficult to remove.The surgeon successfully removed the screw shaft using a radio pincer and a forceps for screw removal.For the fourth locking screw, the surgeon drilled the head of the screw by using a carbide drill.The surgeon succeeded in removing all implants, but the metal powder generated during excavation adhered to the soft parts, so the surgeon cleaned, and tried to remove them, but could not remove them completely.They were remained in the patient's body.The surgery was delayed by ninety (90) minutes and completed successfully.The tka surgery will be performed on an unknown date.No further information is available.This report is for one (1) ti lcp distal femur plate 5 holes/156mm/right-sterile.This is report 1 of 6 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6 - codes updated to imdrf codes.Device history lot - part: 422.250s.Lot: l388377.Manufacturing site: grenchen.Supplier: n/a.Release to warehouse date: 05 may 2017.Expiration date: 01 april 2027.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 5 HOLES/156MM/RIGHT-STERILE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12845398
• MDR Text Key: 285485090
• Report Number: 2939274-2021-06760
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819289581
• UDI-Public: (01)07611819289581
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 422.250S
• Device Lot Number: L388377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - EXTRACTION INSTRUMENTS: TRAUMA; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Sex: Female