MAUDE Adverse Event Report: SYNTHES GMBH CANN-LOCKSCR ø5 L75 TAN; PLATE, FIXATION, BONE

Catalog Number 04.205.075S

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint #(b)(4).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: e3: reporter is a j&j sales representative.D4: the gtin and udi not available in ecm therefore, field was kept blank.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: 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

It was reported that on (b)(6) 2023, the patient underwent unknown surgery with lcp-df plate for distal femur fracture.On(b)(6) 2024, two of screws could not be extracted from the plate, and then, each of its head portion were removed.Both of remaining parts of the shaft one was removed by a screw for removal use.The revision surgery was completed approximately 40 minutes successfully.Patient status/ outcome: reported stable.No further information is available.This report is for one (1) cann-lockscr ã¸5 l75 tan this is report 1 of 2 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.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

It was further reported that the shafts of both extracted screws were observed in somewhat bowed bending condition.The extraction surgery was performed as bone fusion was achieved.There are no pieces in the patient.The surgeon confirmed by x-ray.Patient outcome is reported as stable.

• Brand Name: CANN-LOCKSCR ø5 L75 TAN
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH LOGISTIK; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19133428
• MDR Text Key: 340485130
• Report Number: 8030965-2024-05216
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819903593
• UDI-Public: (01)07611819903593
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.205.075S
• Device Lot Number: 9L31031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CANN-LOCKSCR ø5 L75 TAN; UNK - PLATES: TRAUMA