MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM/3.5MM VA-LCP EXT MEDL DHP 4H/RT/111MM-LONG-STER; PLATE, FIXATION, BONE

Model Number	02.117.604S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an unknown date in 2021.Additional procode: hwc.Part: 02.117.604s.Lot: l092282.Manufacturing site: (b)(4).Release to warehouse date: august 24, 2016.Expiration date: august 01, 2026.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Customer quality investigation: the device was not returned.A photo-investigation was performed on the x-ray image.Upon inspecting the images, the device was observed to be broken in two pieces.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition could be confirmed during photo investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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
Device report from the (b)(6) reports an event as follows: it was reported that a variable angle (va) elbow medial plate that has broken postoperatively.This report is for a 2.7mm/3.5mm va-locking compression plate (lcp).This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP EXT MEDL DHP 4H/RT/111MM-LONG-STER
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12470333
• Report Number: 8030965-2021-07739
• Device Sequence Number: 20046899
• Product Code: HRS
• UDI-Device Identifier: 10886982037015
• UDI-Public: (01)10886982037015
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2021

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 Expiration Date: 08/01/2026
• Device Model Number: 02.117.604S
• Device Catalogue Number: 02.117.604S
• Device Lot Number: L092282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/14/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: 2.7 MM VA LOCKING; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: METAPHYSEAL; VA-LCP DHP 2.7/3.5 LAT R MED 2HO L82 SST