MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: VA-LCP; PLATE,FIXATION,BONE

Device Problem Device-Device Incompatibility (2919)

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

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.Investigation summary: photo investigation: the device was not returned.A photo-investigation was performed on the images provided.The images depicted a screw resting on a screw rack.Plates were observed within a case.No damage, defects, or malfunctions were noted in the images.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 was not confirmed.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 history lot: unknown lot, therefore, a dhr review could not be performed.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during an unknown procedure, the 3.5 va locking screw did not lock the unknown plate.There is no further information available.Concomitant device reported: unknown variable angle plate (part# unknown; lot# unknown; quantity: 1).This report is for one (1) unk - plates.This is report 2 of 2 for (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: d1 d10: therapy date is march 11, 2021.H6: based on the information available, it has been determined that no corrective and 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.E3.

• Brand Name: UNK - PLATES: VA-LCP
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11638247
• MDR Text Key: 246770724
• Report Number: 8030965-2021-02738
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 06/08/2021
• Patient Sequence Number: 1
• Treatment: 3.5 VA LCK SCRW/SLF-TP/STRD/70