MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM/3.5MM LCP® METAPHYSEAL PLATE 12 HOLES; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, MULTI COMPONENT, METAL COMPOSITE

Catalog Number	224.757
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional 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.H11 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H6: without a lot number the device history records review could not be completed.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 or Problem Description
It was reported that bolt was bent when opened.Aiming arm missed nail.Locking screw did not lock into plate after bent.Calibration was off for two depth gauge and two (2) 3.5mm variable angle (va) drill sleeves were not able to thread into handle, unsure if threads were stripped.There was no patient consequences reported.There was no surgical delay.This report is for one (1) 4.5mm/3.5mm lcp® metaphyseal plate 12 holes.This is report 1 of 6 for complaint (b)(4).

• Brand Name: 4.5MM/3.5MM LCP® METAPHYSEAL PLATE 12 HOLES
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, MULTI COMPONENT, METAL COMPOSITE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 19808605
• Report Number: 8030965-2024-09112
• Device Sequence Number: 8389873
• Product Code: LXT
• UDI-Device Identifier: 10886982158710
• UDI-Public: (01)10886982158710
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Catalogue Number: 224.757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Patient Sex: Unknown