MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM LCP PLATE 10 HOLES 137MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 223.601

Device Problem Material Deformation (2976)

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

Event Date 05/03/2023

Event Type  malfunction  

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.H10 additional narrative: d2b: additional product codes: hwc and hrs.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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 Description

It was reported that on (b)(6) 2023, upon post-op inspection of the items, the plate was bent, the suprapatellar caddy was bent and the lid did not fit.The ans inserts had white residue and the samurai sword was deformed.The benders had rust on them.None of the devices were charged to the facility.There were no patient consequences/ outcomes.This report is for one (1) 3.5mm lcp plate 10 holes 137mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 3.5MM LCP PLATE 10 HOLES 137MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16962909
• MDR Text Key: 315576163
• Report Number: 8030965-2023-06317
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982157997
• UDI-Public: (01)10886982157997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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
• Device Operator: Health Professional
• Device Model Number: 223.601
• Device Catalogue Number: 223.601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 05/19/2023; 06/20/2023
• Supplement Dates FDA Received: 06/05/2023; 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BENDING IRON FOR 4.5MM PLATES.; LONG SCALPEL HANDLE.; SCR RACK INSERT F/ IM NL 5 LCKNG SCRS.; TN-ADVANCED SUPRAPATELLAR TRAY.